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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9266
Submission : 1991-07-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13756
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11085
Submission : 1994-09-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9143
Submission : 1991-05-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 488
Submission : 1962-06-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 701
Submission : 1962-08-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11144
Submission : 1994-10-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12638
Submission : 1997-08-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19560
Submission : 2006-06-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8071
Submission : 1989-05-10
Status : Inactive
Type : II
CEP/COS
Certificate Numbers : R1-CEP 2006-064 - Rev 01
Status : Valid
Issue Date : 2013-02-26
Type : Chemical
Substance Number : 1651
CEP/COS
Certificate Numbers : CEP 2019-114 - Rev 01
Status : Valid
Issue Date : 2024-04-26
Type : Chemical
Substance Number : 2357
Certificate Numbers : R1-CEP 2005-102 - Rev 05
Status : Valid
Issue Date : 2020-02-17
Type : Chemical
Substance Number : 924
CEP/COS
Certificate Numbers : R1-CEP 1997-060 - Rev 04
Status : Valid
Issue Date : 2010-06-10
Type : Chemical
Substance Number : 924
Certificate Numbers : R1-CEP 2006-307 - Rev 01
Status : Suspended by EDQM F...
Issue Date : 2013-03-21
Type : Chemical
Substance Number : 2021
CEP/COS
Certificate Numbers : R1-CEP 2009-182 - Rev 01
Status : Valid
Issue Date : 2020-03-13
Type : Chemical
Substance Number : 2245
CEP/COS
Certificate Numbers : R0-CEP 2019-137 - Rev 01
Status : Valid
Issue Date : 2022-09-08
Type : Chemical
Substance Number : 2245
CEP/COS
Certificate Numbers : R1-CEP 1997-063 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2009-06-04
Type : Chemical
Substance Number : 1058
CEP/COS
Certificate Numbers : R1-CEP 1997-132 - Rev 04
Status : Valid
Issue Date : 2009-10-19
Type : Chemical
Substance Number : 573
Details:
The collaboration aims to advance the novel anticoagulant ATI-5923 (tecarfarin), designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices.
Lead Product(s): Tecarfarin
Therapeutic Area: Hematology Brand Name: ATI-5923
Study Phase: Phase IProduct Type: Small molecule
Recipient: Cadrenal Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 06, 2024
Lead Product(s) : Tecarfarin
Therapeutic Area : Hematology
Highest Development Status : Phase I
Recipient : Cadrenal Therapeutics
Deal Size : Undisclosed
Deal Type : Collaboration
Cadrenal and Abbott Collaborate on Novel Anticoagulant Tecarfarin for LVAD Patients
Details : The collaboration aims to advance the novel anticoagulant ATI-5923 (tecarfarin), designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices.
Brand Name : ATI-5923
Molecule Type : Small molecule
Upfront Cash : Undisclosed
August 06, 2024
Details:
The FDA approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System to keep arteries open, delivering Everolimus to support healing in patients with chronic limb-threatening ischemia.
Lead Product(s): Everolimus
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Esprit
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2024
Lead Product(s) : Everolimus
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Abbott's Breakthrough Dissolving Stent Receives FDA Approval for Arteries below the Knee
Details : The FDA approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System to keep arteries open, delivering Everolimus to support healing in patients with chronic limb-threatening ischemia.
Brand Name : Esprit
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 29, 2024
Details:
Under the agreemeent, Abbott will commercialize several biosimilar molecules in key emerging markets in Latin America, Southeast Asia, the Middle East and Africa, and mAbxience will develop, manufacture and supply the biosimilar molecules.
Lead Product(s): Undisclosed
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Large molecule
Recipient: Mabxience
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 20, 2023
Lead Product(s) : Undisclosed
Therapeutic Area : Oncology
Highest Development Status : Undisclosed
Recipient : Mabxience
Deal Size : Undisclosed
Deal Type : Agreement
Abbott Broadens Access to Cutting-edge Biosimilars in Key Emerging Markets
Details : Under the agreemeent, Abbott will commercialize several biosimilar molecules in key emerging markets in Latin America, Southeast Asia, the Middle East and Africa, and mAbxience will develop, manufacture and supply the biosimilar molecules.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Undisclosed
September 20, 2023
Details:
Under the agreement, Abbott has exclusive worldwide commercialization rights for the SurVeil (paclitaxel) drug-coated balloon (DCB) for which Surmodics received FDA approval.
Lead Product(s): Paclitaxel
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: SurVeil
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Surmodics
Deal Size: $92.0 million Upfront Cash: $25.0 million
Deal Type: Agreement June 20, 2023
Lead Product(s) : Paclitaxel
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Recipient : Surmodics
Deal Size : $92.0 million
Deal Type : Agreement
Surmodics Receives FDA Approval for the SurVeil™ Drug-Coated Balloon
Details : Under the agreement, Abbott has exclusive worldwide commercialization rights for the SurVeil (paclitaxel) drug-coated balloon (DCB) for which Surmodics received FDA approval.
Brand Name : SurVeil
Molecule Type : Small molecule
Upfront Cash : $25.0 million
June 20, 2023
Details:
EleCare formulas are hypoallergenic and are used by infants and children who have severe food allergies or gastrointestinal (GI) disorders that require amino acid-based formulas.
Lead Product(s): Amino Acid-Based Therapeutic
Therapeutic Area: Nutrition and Weight Loss Brand Name: Elecare
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2022
Lead Product(s) : Amino Acid-Based Therapeutic
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Abbott to Release Elecare® Amino Acid-Based Formulas to Help Meet Critical Patient Need
Details : EleCare formulas are hypoallergenic and are used by infants and children who have severe food allergies or gastrointestinal (GI) disorders that require amino acid-based formulas.
Brand Name : Elecare
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 24, 2022
Details:
The novel, room-temperature-stable (RTS), single-dose formulation of Carbetocin will address prevailing challenges with existing protocols that require cold-chain storage and transportation.
Lead Product(s): Carbetocin Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2021
Lead Product(s) : Carbetocin Acetate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The novel, room-temperature-stable (RTS), single-dose formulation of Carbetocin will address prevailing challenges with existing protocols that require cold-chain storage and transportation.
Brand Name : Undisclosed
Molecule Type : Peptide
Upfront Cash : Not Applicable
August 31, 2021
Details:
Estradiol, also spelled oestradiol, is an estrogen steroid hormone and the major female sex hormone. It is involved in the regulation of the estrous and menstrual female reproductive cycles.
Lead Product(s): Estradiol,Dydrogesterone
Therapeutic Area: Musculoskeletal Brand Name: Femoston
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2021
Lead Product(s) : Estradiol,Dydrogesterone
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Abbott Gets CDSCO Approval for Marketing of Estradiol, Dydrogesterone FDC
Details : Estradiol, also spelled oestradiol, is an estrogen steroid hormone and the major female sex hormone. It is involved in the regulation of the estrous and menstrual female reproductive cycles.
Brand Name : Femoston
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 15, 2021
Details:
After termination of the agreement, AstraZeneca India will continue to independently market Dapagliflozin, the combinations of Dapagliflozin and Metformin as well as Dapagliflozin and Saxagliptin in India under the brand names Forxiga, Xigduo and Qtern respectively.
Lead Product(s): Dapagliflozin Propanediol Monohydrate,Metformin
Therapeutic Area: Endocrinology Brand Name: Xigduo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: AstraZeneca
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination May 28, 2021
Lead Product(s) : Dapagliflozin Propanediol Monohydrate,Metformin
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : AstraZeneca
Deal Size : Undisclosed
Deal Type : Termination
AstraZeneca Pharma, Abbott Healthcare Terminate Distribution Agreements for Diabetes Drug in India
Details : After termination of the agreement, AstraZeneca India will continue to independently market Dapagliflozin, the combinations of Dapagliflozin and Metformin as well as Dapagliflozin and Saxagliptin in India under the brand names Forxiga, Xigduo and Qtern r...
Brand Name : Xigduo
Molecule Type : Small molecule
Upfront Cash : Undisclosed
May 28, 2021
Details:
This is the first Investigational Device Exemption (IDE) trial in the U.S. to evaluate a fully resorbable device to treat blocked arteries below the knees, or critical limb ischemia (CLI), in people battling advanced stages of peripheral artery disease (PAD).
Lead Product(s): Everolimus
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: ESPRIT BTK
Study Phase: UndisclosedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Lead Product(s) : Everolimus
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Abbott Announces Start of Trial to Evaluate the New Esprit™ BTK Drug-Eluting Resorbable Scaffold
Details : This is the first Investigational Device Exemption (IDE) trial in the U.S. to evaluate a fully resorbable device to treat blocked arteries below the knees, or critical limb ischemia (CLI), in people battling advanced stages of peripheral artery disease (...
Brand Name : ESPRIT BTK
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 03, 2020
Details:
Approval marks the first once-a-day formulation for Ivabradine in India, which will help increase adherence to therapy for chronic heart failure and chronic stable angina.
Lead Product(s): Ivabradine Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2020
Lead Product(s) : Ivabradine Hydrochloride
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Abbott’s Once-A-Day Ivabradine Receives DCGI Approval for Heart Failure and Angina patients
Details : Approval marks the first once-a-day formulation for Ivabradine in India, which will help increase adherence to therapy for chronic heart failure and chronic stable angina.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 02, 2020
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Abbott Laboratories is a supplier offers 115 products (APIs, Excipients or Intermediates).
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