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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15003
Submission : 2000-09-11
Status : Active
Type : II
Certificate Number : R1-CEP 2011-311 - Rev 01
Issue Date : 2021-03-17
Type : Chemical
Substance Number : 2411
Status : Valid
Registration Number : 224MF10100
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein
Initial Date of Registration : 2012-05-23
Latest Date of Registration :
Registrant Name : Boehringer Ingelheim Korea Ltd.
Registration Date : 2013-01-09
Registration Number : 20130109-194-I-63-01
Manufacturer Name : Boehringer Ingelheim GmbH & Co.KG
Manufacturer Address : Binger Strasse 173 55216 Ingelheim am Rhein, Germany
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14259
Submission : 1999-06-25
Status : Active
Type : II
Certificate Number : R1-CEP 1996-005 - Rev 05
Issue Date : 2015-10-08
Type : Chemical
Substance Number : 919
Status : Valid
Registration Number : 220MF10081
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein
Initial Date of Registration : 2008-03-14
Latest Date of Registration :
NDC Package Code : 12714-049
Start Marketing Date : 2011-05-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Boehringer Ingelheim Korea Ltd.
Registration Date : 2012-09-19
Registration Number : 20120919-188-I-64-01
Manufacturer Name : Boehringer Ingelheim Pharma GmbH & Co. K.G.
Manufacturer Address : Binger Strasse 173, 55216 Ingelheim am Rhein
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19620
Submission : 2006-07-24
Status : Active
Type : II
Certificate Number : R1-CEP 2006-123 - Rev 00
Issue Date : 2012-09-25
Type : Chemical
Substance Number : 2135
Status : Valid
Registration Number : 221MF10144
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein
Initial Date of Registration : 2009-07-09
Latest Date of Registration :
Registrant Name : Novo Nordisk Pharmaceuticals Co., Ltd.
Registration Date : 2021-10-28
Registration Number : 20211028-209-J-1132
Manufacturer Name : Boehringer Ingelheim Pharma GmbH & Co KG
Manufacturer Address : Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2002-142 - Rev 03
Issue Date : 2011-02-10
Type : Chemical
Substance Number : 1489
Status : Valid
Registration Number : 220MF10085
Registrant's Address : S. S. 11 Padana Superiore,N. 8 24040 Fornovo San Giovanni
Initial Date of Registration : 2008-03-18
Latest Date of Registration :
Registrant Name : Opella Healthcare Korea Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-45-B-117-04
Manufacturer Name : Bidachem SpA
Manufacturer Address : SS 11(Padana Superiore), 8 24040 Fornovo San Giovanni
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6926
Submission : 1987-04-06
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-147 - Rev 04
Issue Date : 2015-09-25
Type : Chemical
Substance Number : 79
Status : Withdrawn by Holder
Registration Number : 218MF10484
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein Germany
Initial Date of Registration : 2006-05-15
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5822
Submission : 1985-05-29
Status : Inactive
Type : II
Certificate Number : R1-CEP 2009-274 - Rev 00
Issue Date : 2016-03-17
Type : Chemical
Substance Number : 2303
Status : Withdrawn by Holder
Registration Number : 218MF10483
Registrant's Address : Binger Strasse 173, 55216 Ingelheim am Rhein Germany
Initial Date of Registration : 2006-05-15
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18148
Submission : 2005-02-21
Status : Inactive
Type : II
Certificate Number : R1-CEP 2002-010 - Rev 02
Issue Date : 2010-07-08
Type : Chemical
Substance Number : 922
Status : Withdrawn by Holder
Registration Number : 218MF10395
Registrant's Address : S. S. 11 Padana Superior N. 8 24040 Fornovo S. Giovanni BG Italy
Initial Date of Registration : 2006-03-20
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21413
Submission : 2008-03-12
Status : Active
Type : II
Certificate Number : R0-CEP 2019-186 - Rev 00
Issue Date : 2020-04-02
Type : Chemical
Substance Number : 2416
Status : Valid
Registrant Name : Boehringer Ingelheim Korea Ltd.
Registration Date : 2022-05-17
Registration Number : 20220517-209-J-1298
Manufacturer Name : Boehringer Ingelheim Pharma GmbH & Co. K.G.
Manufacturer Address : Binger Strasse 173, 55216 Ingelheim am Rhien, Germany
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14258
Submission : 1999-06-25
Status : Active
Type : II
Certificate Number : CEP 1997-004 - Rev 05
Issue Date : 2024-05-30
Type : Chemical
Substance Number : 687
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3622
Submission : 1979-08-23
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-064 - Rev 01
Issue Date : 2008-09-09
Type : Chemical
Substance Number : 106
Status : Withdrawn by Holder
Registration Number : 221MF10105
Registrant's Address : Binger Strasse 173, 55216 Ingelheim am Rhein
Initial Date of Registration : 2009-05-27
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14258
Submission : 1999-06-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2314
Submission : 1974-08-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5791
Submission : 1985-03-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7334
Submission : 1988-02-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5494
Submission : 1984-01-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6024
Submission : 1985-09-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5753
Submission : 1954-03-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5980
Submission : 1985-08-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11714
Submission : 1995-10-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13618
Submission : 1998-09-01
Status : Inactive
Type : II
CEP/COS
Certificate Numbers : R1-CEP 2009-274 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2016-03-17
Type : Chemical
Substance Number : 2303
CEP/COS
Certificate Numbers : R1-CEP 1999-193 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2009-11-17
Type : Chemical
Substance Number : 254
CEP/COS
Certificate Numbers : R1-CEP 2002-142 - Rev 03
Status : Valid
Issue Date : 2011-02-10
Type : Chemical
Substance Number : 1489
CEP/COS
Certificate Numbers : R1-CEP 2010-150 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2017-03-17
Type : Chemical
Substance Number : 2056
CEP/COS
Certificate Numbers : R1-CEP 2000-299 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2011-02-18
Type : Chemical
Substance Number : 68
CEP/COS
Certificate Numbers : R1-CEP 2003-067 - Rev 00
Status : Valid
Issue Date : 2010-01-07
Type : Chemical
Substance Number : 595
CEP/COS
Certificate Numbers : R1-CEP 2004-037 - Rev 00
Status : Valid
Issue Date : 2010-01-07
Type : Chemical
Substance Number : 595
CEP/COS
Certificate Numbers : R1-CEP 2002-025 - Rev 02
Status : Valid
Issue Date : 2015-12-14
Type : Chemical
Substance Number : 706
CEP/COS
Certificate Numbers : R1-CEP 2008-063 - Rev 00
Status : Valid
Issue Date : 2014-10-31
Type : Chemical
Substance Number : 2197
CEP/COS
Certificate Numbers : R1-CEP 2000-122 - Rev 03
Status : Valid
Issue Date : 2014-10-10
Type : Chemical
Substance Number : 1409
Registration Number : 220MF10085
Registrant's Address : S. S. 11 Padana Superiore,N. 8 24040 Fornovo San Giovanni
Initial Date of Registration : 2008-03-18
Latest Date of Registration : 2008-03-18
Registration Number : 219MF10046
Registrant's Address : S. S. 11 Padana Superiore,N. 8 24040 Fornovo San Giovanni
Initial Date of Registration : 2007-02-13
Latest Date of Registration : 2007-02-13
JDMF
Registration Number : 218MF10484
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein Germany
Initial Date of Registration : 2006-05-15
Latest Date of Registration : 2015-12-15
Registration Number : 224MF10100
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein
Initial Date of Registration : 2012-05-23
Latest Date of Registration : 2017-10-06
JDMF
Registration Number : 218MF10483
Registrant's Address : Binger Strasse 173, 55216 Ingelheim am Rhein Germany
Initial Date of Registration : 2006-05-15
Latest Date of Registration : 2015-12-15
Registration Number : 218MF10495
Registrant's Address : 2820 North Normandy Drive Petersburg, Virginia 23805
Initial Date of Registration : 2006-05-15
Latest Date of Registration : 2010-03-25
Registration Number : 220MF10081
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein
Initial Date of Registration : 2008-03-14
Latest Date of Registration : 2023-11-08
JDMF
Registration Number : 218MF10395
Registrant's Address : S. S. 11 Padana Superior N. 8 24040 Fornovo S. Giovanni BG Italy
Initial Date of Registration : 2006-03-20
Latest Date of Registration : 2006-08-23
Registration Number : 220MF10132
Registrant's Address : S. S. 11 Padana Superiore,N. 8 24040 Fornovo San Giovanni
Initial Date of Registration : 2008-05-20
Latest Date of Registration : 2015-05-01
JDMF
Registration Number : 221MF10144
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein
Initial Date of Registration : 2009-07-09
Latest Date of Registration : 2017-05-16
Registrant Name : Opella Healthcare Korea Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-45-B-117-04
Manufacturer Name : Bidachem SpA
Manufacturer Address : SS 11(Padana Superiore), 8 24040 Fornovo San Giovanni
Registrant Name : Boehringer Ingelheim Korea Ltd.
Registration Date : 2010-10-11
Registration Number : Su426-2-ND
Manufacturer Name : Bidachem SpA
Manufacturer Address : Strada Statale 11 (Padana Superiore), N.8 24040 Fornovo San Giovanni (BG) ITALY
Registrant Name : Boehringer Ingelheim Korea Ltd.
Registration Date : 2010-10-11
Registration Number : Su426-1-ND
Manufacturer Name : Boehringer Ingelheim Pharma Gm...
Manufacturer Address : Binger Strasse 173, 55216 Ingelheim am Rhein
Registrant Name : Boehringer Ingelheim Korea Ltd.
Registration Date : 2018-01-15
Registration Number : 15-8-ND
Manufacturer Name : (Except for micronization proc...
Manufacturer Address : Strada Statale 11 (Padana Superiore), N. 8, 24040 Fornovo San Giovanni (BG), ITALY@Bi...
Registrant Name : Boehringer Ingelheim Korea Ltd.
Registration Date : 2014-05-21
Registration Number : No. 2807-5-ND
Manufacturer Name : Boehringer Ingelheim Pharma Gm...
Manufacturer Address : Binger Straβe 173, D-55216 Ingelheim, Germany
Registrant Name : Boehringer Ingelheim Korea Ltd.
Registration Date : 2013-01-09
Registration Number : 20130109-194-I-63-01
Manufacturer Name : Boehringer Ingelheim GmbH & Co...
Manufacturer Address : Binger Strasse 173 55216 Ingelheim am Rhein, Germany
Registrant Name : Boehringer Ingelheim Korea Ltd.
Registration Date : 2012-09-19
Registration Number : 20120919-188-I-64-01
Manufacturer Name : Boehringer Ingelheim Pharma Gm...
Manufacturer Address : Binger Strasse 173, 55216 Ingelheim am Rhein
Registrant Name : Boehringer Ingelheim Korea Ltd.
Registration Date : 2012-11-14
Registration Number : 20121114-148-I-85-06
Manufacturer Name : Bidachem SpA
Manufacturer Address : Strada Statale 11(Padana Superiore), N. 8, 24040 Fornovo San Giovanni (BG), Italy
Registrant Name : Boehringer Ingelheim Korea Ltd.
Registration Date : 2015-07-13
Registration Number : No. 2807-7-ND
Manufacturer Name : Boehringer Ingelheim Pharma Gm...
Manufacturer Address : Binger Straße 173, D-55216 Ingelheim, Germany
Registrant Name : Heilion Korea Co., Ltd.
Registration Date : 2008-06-27
Registration Number : 20080627-88-D-82-06
Manufacturer Name : Boehringer Ingelheim Pharma Gm...
Manufacturer Address : 55216 Ingelheim Binger Str.173
NDC Package Code : 12714-213
Start Marketing Date : 2015-01-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1.1mg/1.1mg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 12714-083
Start Marketing Date : 1987-11-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100mg/100mg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 12714-082
Start Marketing Date : 1987-11-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50mg/50mg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 12714-034
Start Marketing Date : 2004-09-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 12714-031
Start Marketing Date : 2001-07-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51869-0009
Start Marketing Date : 2016-04-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1000g/1000g)
Marketing Category : EXPORT ONLY
NDC Package Code : 12714-011
Start Marketing Date : 2019-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51869-0030
Start Marketing Date : 2011-08-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51869-0015
Start Marketing Date : 2016-02-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 12714-201
Start Marketing Date : 2016-02-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Details:
BI 1820237 is a potent, specific peptidic NPY2R agonist in development for the treatment of overweight/obesity via once-weekly subcutaneous injection
Lead Product(s): BI 1820237,BI 456906
Therapeutic Area: Nutrition and Weight Loss Brand Name: BI 1820237
Study Phase: Phase IProduct Type: Peptide
Recipient: Gubra
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 31, 2024
Lead Product(s) : BI 1820237,BI 456906
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase I
Recipient : Gubra
Deal Size : Not Applicable
Deal Type : Not Applicable
Boehringer Drops Obesity Drug from Gubra Partnership
Details : BI 1820237 is a potent, specific peptidic NPY2R agonist in development for the treatment of overweight/obesity via once-weekly subcutaneous injection
Brand Name : BI 1820237
Molecule Type : Peptide
Upfront Cash : Not Applicable
October 31, 2024
Details:
The collaboration aims to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers.
Lead Product(s): Macrocycle-based Therapy
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Small molecule
Recipient: Circle Pharma
Deal Size: $607.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration October 09, 2024
Lead Product(s) : Macrocycle-based Therapy
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Recipient : Circle Pharma
Deal Size : $607.0 million
Deal Type : Collaboration
Boehringer Ingelheim and Circle Pharma Announce Precision Cancer Treatment Pact
Details : The collaboration aims to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 09, 2024
Details:
BI456906 (survodutide) is a glucagon/GLP-1 receptor dual agonist with a novel mechanism of action. It is being evaluated for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
Lead Product(s): Survodutide
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: BI 456906
Study Phase: Phase IIIProduct Type: Peptide
Recipient: Zealand Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2024
Lead Product(s) : Survodutide
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Recipient : Zealand Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Zealand, Boehringer Win FDA Breakthrough Status to Treat Fatty Liver
Details : BI456906 (survodutide) is a glucagon/GLP-1 receptor dual agonist with a novel mechanism of action. It is being evaluated for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
Brand Name : BI 456906
Molecule Type : Peptide
Upfront Cash : Not Applicable
October 07, 2024
Details:
Surrozen collaborates with Boehringer to research & develop SZN-413 to treat retinal diseases and will receive an exclusive, worldwide license to develop other Fzd4-specific Wnt-modulating molecules.
Lead Product(s): SZN-413
Therapeutic Area: Ophthalmology Brand Name: SZN-413
Study Phase: PreclinicalProduct Type: Large molecule
Recipient: Surrozen
Deal Size: $599.0 million Upfront Cash: $12.5 million
Deal Type: Collaboration September 24, 2024
Lead Product(s) : SZN-413
Therapeutic Area : Ophthalmology
Highest Development Status : Preclinical
Recipient : Surrozen
Deal Size : $599.0 million
Deal Type : Collaboration
Surrozen Earns $10 Million Milestone Payment in Retinal Diseases Collaboration
Details : Surrozen collaborates with Boehringer to research & develop SZN-413 to treat retinal diseases and will receive an exclusive, worldwide license to develop other Fzd4-specific Wnt-modulating molecules.
Brand Name : SZN-413
Molecule Type : Large molecule
Upfront Cash : $12.5 million
September 24, 2024
Details:
BI 1015550 (nerandomilast) is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being studied as a potential treatment for idiopathic pulmonary fibrosis.
Lead Product(s): Nerandomilast
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: BI 1015550
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2024
Lead Product(s) : Nerandomilast
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Boehringer’s Nerandomilast Meets Primary Endpoint in FIBRONEER™-IPF Study
Details : BI 1015550 (nerandomilast) is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being studied as a potential treatment for idiopathic pulmonary fibrosis.
Brand Name : BI 1015550
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 16, 2024
Details:
BI 1810631 (zongertinib) is an investigational oral HER2 tyrosine kinase inhibitor (TKI) in development being investigated in patients with advanced NSCLC with activating HER2 mutations.
Lead Product(s): Zongertinib
Therapeutic Area: Oncology Brand Name: BI 1810631
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2024
Lead Product(s) : Zongertinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Boehringer’s Zongertinib Shows Efficacy in HER2 Mutated Lung Cancer Patients
Details : BI 1810631 (zongertinib) is an investigational oral HER2 tyrosine kinase inhibitor (TKI) in development being investigated in patients with advanced NSCLC with activating HER2 mutations.
Brand Name : BI 1810631
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 09, 2024
Details:
BI 771716, developed with technology licensed from CDR-Life, is a highly specific antibody fragment of reduced size, enabling an optimized penetration in patients with GA disease pathology.
Lead Product(s): BI 771716
Therapeutic Area: Ophthalmology Brand Name: BI 771716
Study Phase: Phase IProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 05, 2024
Lead Product(s) : BI 771716
Therapeutic Area : Ophthalmology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Boehringer Ingelheim Advances Treatment for Geographic Atrophy after Phase I Success
Details : BI 771716, developed with technology licensed from CDR-Life, is a highly specific antibody fragment of reduced size, enabling an optimized penetration in patients with GA disease pathology.
Brand Name : BI 771716
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 05, 2024
Details:
Through the acquisition, Boehringer will leverage the Nerio oncology Pipeline, which consists of small molecules that inhibit the PTPN1/2, enhance immune function, and sensitize tumors.
Lead Product(s): Undisclosed
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Small molecule
Recipient: Nerio Therapeutics
Deal Size: $1,300.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition July 29, 2024
Boehringer Buys Nerio Therapeutics for $1.3B to Boost Immuno-Oncology Pipeline
Details : Through the acquisition, Boehringer will leverage the Nerio oncology Pipeline, which consists of small molecules that inhibit the PTPN1/2, enhance immune function, and sensitize tumors.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
July 29, 2024
Details:
Spevigo (spesolimab) is an IL-36 blocker, given by IV infusion, has been approved by CDSCO as the first treatment option for generalized pustular psoriasis flares in adults.
Lead Product(s): Spesolimab
Therapeutic Area: Dermatology Brand Name: Spevigo
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 29, 2024
Lead Product(s) : Spesolimab
Therapeutic Area : Dermatology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
CHMP Adopts Positive Opinion for Expanded SPEVIGO® Indications
Details : Spevigo (spesolimab) is an IL-36 blocker, given by IV infusion, has been approved by CDSCO as the first treatment option for generalized pustular psoriasis flares in adults.
Brand Name : Spevigo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 29, 2024
Details:
NBL-001 (volasertib) is a PLK-1 inhibitor, small molecule drug candidate. It is being evaluated for the treatment of relapsed/refractory acute myeloid leukemia.
Lead Product(s): Volasertib
Therapeutic Area: Oncology Brand Name: NBL-001
Study Phase: Phase IProduct Type: Small molecule
Recipient: Notable Labs
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 24, 2024
Lead Product(s) : Volasertib
Therapeutic Area : Oncology
Highest Development Status : Phase I
Recipient : Notable Labs
Deal Size : Not Applicable
Deal Type : Not Applicable
Notable Labs Receives FDA Clearance to Proceed Further with Volasertib Phase 2 Study
Details : NBL-001 (volasertib) is a PLK-1 inhibitor, small molecule drug candidate. It is being evaluated for the treatment of relapsed/refractory acute myeloid leukemia.
Brand Name : NBL-001
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 24, 2024
Regulatory Info : OTC
Registration Country : Canada
Dosage Form : SOLUTION
Brand Name : ATRAVET 10 MG INJECTABLE
Dosage Strength : 10MG/ML
Packaging : 50 ML
Approval Date :
Application Number : 53023
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info :
Registration Country : Italy
Acetaminophen/Paracetamol; Chlorpheniramine
Dosage Form :
Brand Name : Zerinetta C.M.
Dosage Strength : 10 Supp 150 Mg + 1 Mg ...
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET;ORAL
Brand Name : ACETAMINOPHEN AND CODEINE...
Dosage Strength : 500MG;15MG
Packaging :
Approval Date : 1989-04-25
Application Number : 89511
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET;ORAL
Brand Name : ACETAMINOPHEN AND CODEINE...
Dosage Strength : 500MG;60MG
Packaging :
Approval Date : 1989-04-25
Application Number : 89513
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET;ORAL
Brand Name : ACETAMINOPHEN AND CODEINE...
Dosage Strength : 300MG;15MG
Packaging :
Approval Date : 1982-01-01
Application Number : 84659
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET;ORAL
Brand Name : ACETAMINOPHEN AND CODEINE...
Dosage Strength : 500MG;30MG
Packaging :
Approval Date : 1989-04-25
Application Number : 89512
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET;ORAL
Brand Name : ACETAMINOPHEN AND CODEINE...
Dosage Strength : 300MG;30MG
Packaging :
Approval Date : 1982-01-01
Application Number : 84656
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET;ORAL
Brand Name : ACETAMINOPHEN AND CODEINE...
Dosage Strength : 300MG;60MG
Packaging :
Approval Date : 1982-01-01
Application Number : 84667
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Brand Name : ROXILOX
Dosage Strength : 500MG;5MG
Packaging :
Approval Date : 1995-07-03
Application Number : 40061
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Brand Name : ROXICET 5/500
Dosage Strength : 500MG;5MG
Packaging :
Approval Date : 1989-01-12
Application Number : 89775
Regulatory Info : DISCN
Registration Country : USA
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 300MG;30MG
Approval Date : 1982-01-01
Application Number : 84656
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 300MG;15MG
Approval Date : 1982-01-01
Application Number : 84659
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 300MG;60MG
Approval Date : 1982-01-01
Application Number : 84667
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 500MG;15MG
Approval Date : 1989-04-25
Application Number : 89511
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 500MG;30MG
Approval Date : 1989-04-25
Application Number : 89512
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 500MG;60MG
Approval Date : 1989-04-25
Application Number : 89513
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Dosage Form : CAPSULE; ORAL
Proprietary Name : ROXILOX
Dosage Strength : 500MG;5MG
Approval Date : 1995-07-03
Application Number : 40061
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Proprietary Name : ROXICET 5/500
Dosage Strength : 500MG;5MG
Approval Date : 1989-01-12
Application Number : 89775
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : SOLUTION; INHALATION, ORAL
Proprietary Name : ACETYLCYSTEINE
Dosage Strength : 10%
Approval Date : 1992-04-30
Application Number : 72323
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : SOLUTION; INHALATION, ORAL
Proprietary Name : ACETYLCYSTEINE
Dosage Strength : 10%
Approval Date : 1992-09-30
Application Number : 72621
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Regulatory Info :
Registration Country : Germany
Dosage Form : Injection
Brand Name :
Dosage Strength : 1.8G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Germany
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