Registrants (1)
Northwind Pharmaceuticals, LLC
036986393
Manufacturing Establishments (1)
EPM Packaging
Northwind Pharmaceuticals, LLC
Northwind Pharmaceuticals, LLC
079124340
Products (1)
ACETAMINOPHEN AND CODEINE PHOSPHATE
51655-910
ANDA211610
ANDA (C73584)
ORAL
June 14, 2023
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
AcetaminophenActive
Code: 362O9ITL9DClass: ACTIBQuantity: 300 mg in 1 1
CodeineActive
Code: GSL05Y1MN6Class: ACTIBQuantity: 30 mg in 1 1