Abbott Laboratories
Overview
Abbott Laboratories, a global healthcare company, focuses on the research and development, manufacture, and sale of a broad and diversified line of health care products. It operates through four segments: Established Pharmaceutical Products, Diagnostic Products, Nutritional Products, and Medical Devices.
Therapeutic areas
API / Drug Master Files
Abbott Laboratories holds 2 active (36 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.
- LACTULOSE CONCENTRATE USPActive1993-03-19
- VERAPAMIL HYDROCHLORIDEActive1987-06-04
- HYDROCODONE/ACETAMINOPHEN EXTENDED RELEASE TABLETSInactive2006-08-04
- FENOFIBRATE SPRAY GRANULATION INTERMEDIATEInactive2003-10-10
- AMIKACIN SULFATEInactive1998-09-01
- CLINDAMYCIN HYDROCHLORIDEInactive1998-09-01
- BUTORPHANOL TARTRATE USPInactive1998-03-27
- TROMETHAMINE,USPInactive1997-08-29
- SIMETHICONE COATED CELLULOSE (SONORX); MANFACTURED IN NORTH CHICAGO, ILInactive1996-08-20
- D-CHIRO-INOSITOLInactive1996-06-28
- MSI-78Inactive1995-07-07
- ATRACURIUM BESYLATEInactive1994-10-21
- AMRINONEInactive1994-09-14
- SEMI-WORKS AREA IN QUEENBOROUGH, KENT, UNITED KINGDOMInactive1993-05-28
- PROTIRELIN (TRH)Inactive1993-05-14
Showing 15 of 36 Drug Master Files.
FDA compliance signals
6 FDA enforcement records linked to this company.
- recall — Class II2013-01-09
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
- recall — Class II2012-10-03
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
- recall — Class II2012-10-03
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
- recall — Class II2012-10-03
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
- recall — Class II2012-06-27
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
- warning_letter2009-07-14
FDA Warning Letter (drug product)
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 14 days.