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11-14 November, 2024
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11-13 November, 2024
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CPhI India 2024CPhI India 2024
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26-28 November, 2024
Industry Trade Show
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11-14 November, 2024
The Pharmacy Technolog...The Pharmacy Technology
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11-13 November, 2024
Digital content
INTERVIEW #SpeakPharma
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07 Nov 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/viatris-reports-third-quarter-financial-results-for-2024-302298689.html
05 Nov 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/viatris-announces-third-quarter-2024-dividend-302296180.html
29 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/viatris-named-to-forbes-worlds-top-companies-for-women-2024-list-302290273.html
29 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/viatris-to-participate-in-the-ubs-global-healthcare-conference-and-jefferies-london-healthcare-conference-302290043.html
16 Oct 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/10/16/2964507/0/en/Lexicon-Announces-Exclusive-Licensing-Agreement-With-Viatris-for-Sotagliflozin-in-All-Markets-Outside-of-the-U-S-and-Europe.html
16 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/viatris-announces-exclusive-licensing-agreement-with-lexicon-pharmaceuticals-for-sotagliflozin-in-all-markets-outside-of-the-us-and-europe-302278473.html
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-26
Pay. Date : 2012-11-19
DMF Number : 13277
Submission : 1998-10-22
Status : Active
Type : II
Registration Number : 218MF10974
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2006-12-01
Latest Date of Registration :
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-600
Start Marketing Date : 2015-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2018-05-04
Registration Number : 20050831-33-A-83-09(3)
Manufacturer Name : Mylan Laboratories Limited
Manufacturer Address : 14, 99 & 100, Industrial Development Area Pashamylaram, Phase-II, Patancheru, 502 307, Medak District, Telangana, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-22
Pay. Date : 2013-01-07
DMF Number : 26657
Submission : 2013-01-15
Status : Active
Type : II
Registration Number : 230MF10138
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2018-10-01
Latest Date of Registration :
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-820
Start Marketing Date : 2015-08-20
End Marketing Date : 2026-12-01
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17912
Submission : 2004-12-20
Status : Active
Type : II
Registration Number : 228MF10138
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2016-07-27
Latest Date of Registration :
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-27
Pay. Date : 2013-02-06
DMF Number : 17739
Submission : 2004-10-08
Status : Active
Type : II
Registration Number : 219MF10105
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2007-03-23
Latest Date of Registration :
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-624
Start Marketing Date : 2015-01-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-11-16
Pay. Date : 2015-11-06
DMF Number : 19555
Submission : 2006-06-27
Status : Active
Type : II
Registration Number : 227MF10198
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2015-08-06
Latest Date of Registration :
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-658
Start Marketing Date : 2015-01-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-04-21
Pay. Date : 2020-03-31
DMF Number : 34226
Submission : 2019-10-15
Status : Active
Type : II
Registration Number : 302MF10144
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills,Hyderabad-500096,Telangana,India
Initial Date of Registration : 2020-12-07
Latest Date of Registration :
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-898
Start Marketing Date : 2020-10-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-11
Pay. Date : 2015-09-03
DMF Number : 19098
Submission : 2006-01-10
Status : Active
Type : II
Registration Number : 227MF10282
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2015-12-15
Latest Date of Registration :
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-653
Start Marketing Date : 2015-01-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-07
Pay. Date : 2014-02-04
DMF Number : 23766
Submission : 2010-04-27
Status : Active
Type : II
Registration Number : 228MF10114
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2016-06-17
Latest Date of Registration :
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-752
Start Marketing Date : 2015-01-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-13
Pay. Date : 2019-08-09
DMF Number : 17943
Submission : 2004-12-29
Status : Active
Type : II
Registration Number : 224MF10156
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2012-08-16
Latest Date of Registration :
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-629
Start Marketing Date : 2015-01-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharma Science Korea Co., Ltd.
Registration Date : 2022-10-31
Registration Number : 20221031-209-J-1353
Manufacturer Name : Mylan Laboratories Limited (Unit-7)
Manufacturer Address : Plot No. 14, 99 & 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District 502307, Telangana State, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16409
Submission : 2003-04-23
Status : Active
Type : II
Registration Number : 217MF10578
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2005-09-14
Latest Date of Registration :
Date of Issue : 2019-06-03
Valid Till : 2022-06-02
Written Confirmation Number : WC-0015
Address of the Firm :
NDC Package Code : 65015-606
Start Marketing Date : 2015-02-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22165
Submission : 2008-11-10
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-16
Pay. Date : 2017-05-11
DMF Number : 18229
Submission : 2005-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36475
Submission : 2021-12-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34305
Submission : 2019-11-15
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-19
DMF Number : 13277
Submission : 1998-10-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26117
Submission : 2012-05-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20402
Submission : 2007-04-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16409
Submission : 2003-04-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-08
Pay. Date : 2012-11-06
DMF Number : 20424
Submission : 2007-03-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18214
Submission : 2005-03-30
Status : Active
Type : II
CEP/COS
Certificate Numbers : CEP 2001-342 - Rev 04
Status : Valid
Issue Date : 2024-01-03
Type : Chemical
Substance Number : 1491
CEP/COS
Certificate Numbers : CEP 2021-215 - Rev 01
Status : Valid
Issue Date : 2024-01-04
Type : Chemical
Substance Number : 1491
CEP/COS
Certificate Numbers : R0-CEP 2007-306 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2011-11-08
Type : Chemical
Substance Number : 703
CEP/COS
Certificate Numbers : R0-CEP 2017-008 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2019-12-18
Type : Chemical
Substance Number : 369
CEP/COS
Certificate Numbers : R0-CEP 2013-359 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2017-09-27
Type : Chemical
Substance Number : 2762
CEP/COS
Certificate Numbers : R1-CEP 2010-001 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2019-08-13
Type : Chemical
Substance Number : 1089
CEP/COS
Certificate Numbers : R1-CEP 2006-072 - Rev 05
Status : Withdrawn by Holder
Issue Date : 2019-06-03
Type : Chemical
Substance Number : 888
CEP/COS
Certificate Numbers : R0-CEP 2012-174 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2017-09-18
Type : Chemical
Substance Number : 2531
CEP/COS
Certificate Numbers : R0-CEP 2016-082 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2019-12-18
Type : Chemical
Substance Number : 1691
CEP/COS
Certificate Numbers : R0-CEP 2012-176 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2017-09-18
Type : Chemical
Substance Number : 712
JDMF
Registration Number : 218MF10974
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2013-01-18
Registration Number : 220MF10178
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2008-07-31
Latest Date of Registration : 2008-07-31
JDMF
Registration Number : 217MF10578
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2005-09-14
Latest Date of Registration : 2009-07-30
Registration Number : 229MF10128
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2017-07-14
Latest Date of Registration : 2017-07-14
JDMF
Registration Number : 301MF10062
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2019-09-11
Latest Date of Registration : 2019-09-11
JDMF
Registration Number : 229MF10210
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2017-12-01
Latest Date of Registration : 2017-12-01
JDMF
Registration Number : 304MF10002
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2022-01-11
Latest Date of Registration : 2022-01-11
JDMF
Registration Number : 218MF10768
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2006-09-22
Latest Date of Registration : 2012-06-22
JDMF
Registration Number : 304MF10150
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2022-11-30
Latest Date of Registration : 2022-11-30
JDMF
Registration Number : 302MF10155
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2020-12-18
Latest Date of Registration : 2020-12-18
NDC Package Code : 65015-640
Start Marketing Date : 2015-02-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65015-600
Start Marketing Date : 2015-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65015-683
Start Marketing Date : 2015-02-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65015-606
Start Marketing Date : 2015-02-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65015-673
Start Marketing Date : 2015-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65015-634
Start Marketing Date : 2015-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65015-793
Start Marketing Date : 2015-02-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65015-670
Start Marketing Date : 2015-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65427-003
Start Marketing Date : 2014-07-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65015-897
Start Marketing Date : 2020-08-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...
About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...
About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...
About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...
About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...
About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...
About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...
About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...
About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...
About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...
RLD :
TE Code :
MATRIX LABORATORIES XIAMEN LTD.
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE
Dosage Strength : 300MG
Approval Date :
Application Number : 78742
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE
Dosage Strength : EQ 300MG BASE
Approval Date : 2012-06-18
Application Number : 91294
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE
Dosage Strength : 60 MG
Approval Date :
Application Number : 200733
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE; LAMIVU...
Dosage Strength : 600MG; 300MG
Approval Date :
Application Number : 90519
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE; LAMIVU...
Dosage Strength : 60MG; 30MG
Approval Date :
Application Number : 202381
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE, LAMIVU...
Dosage Strength : EQ 300MG BASE; 150MG; 30...
Approval Date :
Application Number : 90309
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : EPZICOM
Dosage Strength : 600MG;300MG
Approval Date :
Application Number : 204004
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : TABLET; ORAL SUSPENSION
Proprietary Name : ABACAVIR AND LAMIVUDINE
Dosage Strength : 120MG;60MG
Approval Date :
Application Number : 204915
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ABIRATERONE ACETATE
Dosage Strength : 250MG
Approval Date : 2018-10-31
Application Number : 208446
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ABIRATERONE ACETATE
Dosage Strength : 500MG
Approval Date : 2020-12-14
Application Number : 208446
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Regulatory Info :
Registration Country : Italy
Dosage Form : Idarubicin 10Mg 10Ml 1 Units P...
Dosage Strength : 1 vial EV 10 mg/10 ml
Packaging :
Brand Name : Idarubicin
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Filmtabl
Dosage Strength : 1000mg
Packaging :
Brand Name : Abirateron Viatris
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Filmtabl
Dosage Strength : 500mg
Packaging :
Brand Name : Abirateron Viatris
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Norway
Dosage Form : Inhalation liquid for nebulize...
Dosage Strength : 200 mg/ml
Packaging : Vials 10 10ml
Brand Name : Mucomyst
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Inhalation liquid for nebulize...
Dosage Strength : 200 mg/ml
Packaging : Vials 1 10ml
Brand Name : Mucomyst
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Effervescent tablet
Dosage Strength : 200 mg
Packaging : Plastic pipe 25...
Brand Name : Mucomyst
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Effervescent tablet
Dosage Strength : 200 mg
Packaging : Plastic pipe 4 2...
Brand Name : Mucomyst
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Inhalation liquid for nebulize...
Dosage Strength : 200 mg/ml
Packaging : Vials 5 10ml
Brand Name : Mucomyst
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Dosage Form : Gastro-Resistant Tablets
Dosage Strength : 100 mg
Packaging : 30 UNITS 100 MG - ...
Brand Name : ACETYLSALICYLIC ACID MYLAN
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Tabl
Dosage Strength : 500mg
Packaging :
Brand Name : Cyclokapron
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Excipients
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38630
Submission : 2023-08-21
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37682
Submission : 2022-12-02
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22569
Submission : 2009-02-23
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37813
Submission : 2023-03-28
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11884
Submission : 1996-03-04
Status : Inactive
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14785
Submission : 2000-03-16
Status : Inactive
Type : IV
Inspections and registrations
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