Registrants (1)
Blenheim Pharmacal, Inc.
171434587
Manufacturing Establishments (1)
Blenheim Pharmacal, Inc.
Blenheim Pharmacal, Inc.
Blenheim Pharmacal, Inc.
171434587
Products (1)
Acetaminophen and Codeine
10544-100
ANDA089805
ANDA (C73584)
ORAL
December 31, 2013
AcetaminophenActive
Code: 362O9ITL9DClass: ACTIBQuantity: 300 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CodeineActive
Code: GSL05Y1MN6Class: ACTIBQuantity: 30 mg in 1 1
POVIDONESInactive
Code: FZ989GH94EClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT