Abbvie Inc.
Overview
AbbVie Inc. is a global, research-based biopharmaceutical company that develops and markets therapies for serious health challenges. Known for its innovative approach, AbbVie focuses on areas including immunology, oncology, virology, and neuroscience.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Abbvie Inc. is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
Abbvie Inc. holds 7 active (15 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- ERYTHROMYCIN BASEActive2015-11-10
- PARICALCITOL DRUG SUBSTANCEActive2010-11-30
- ERYTHROMYCIN ETHYLSUCCINATEActive1998-09-01
- CYCLOSPORINE USPActive1998-09-01
- ERYTHROMYCIN STEARATEActive1998-09-01
- ERYTHROMYCIN BASEActive1998-04-30
- BUTORPHANOL TARTRATEActive1990-12-20
- NIACIN CORE TABLET INTERMEDIATEInactive2008-10-31
- CHOLINE FENOFIBRATE MINI-TABLET INTERMEDIATEInactive2007-11-13
- CHOLINE FENOFIBRATE DRUG SUBSTANCEInactive2007-11-13
- 5-DESOSAMINYL-6-0-METHYL ERYTHRONOLIDEInactive1999-12-22
- CLINDAMYCIN PHOSPHATEInactive1998-09-01
- ERYTHROMYCIN BASEInactive1998-09-01
- CLORAZEPATE DIPOTASSIUM (TRANXENE)Inactive1982-05-07
- PRAMOXINE HCLInactive1982-04-30
FDA compliance signals
20 FDA enforcement records linked to this company.
- recall — Class III2026-06-03
Failed Stability Specifications
- recall — Class II2024-10-02
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
- recall — Class II2024-10-02
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
- 4832024-04-18
Scientifically sound laboratory controls
- 4832024-04-18
Investigations of discrepancies, failures
- recall — Class III2023-11-15
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
- 4832018-07-02
Late submission of 15-day report
- recall — Class III2018-02-07
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
- recall — Class III2017-11-01
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
- recall — Class III2017-11-01
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
- recall — Class II2017-03-08
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
- recall — Class III2016-04-27
Failed Content Uniformity Specifications
- 4832015-08-06
Procedures to be written and followed
- recall — Class II2014-10-08
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
- recall — Class II2014-05-07
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
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