Registrants (1)
Manufacturing Establishments (1)
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
080355546
Products (1)
Diclofenac Sodium Delayed Release
70934-122
ANDA075185
ANDA (C73584)
ORAL
January 5, 2023
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
POLYETHYLENE GLYCOL 2000Inactive
Code: HAF0412YITClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
DiclofenacActive
Code: QTG126297QClass: ACTIBQuantity: 50 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT