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.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Abbott Laboratories 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
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)
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