MedPath
FDA Approval

Diclofenac Sodium

July 1, 2022

HUMAN PRESCRIPTION DRUG LABEL

Diclofenac(75 mg in 1 1)

Manufacturing Establishments (1)

Proficient Rx LP

Proficient Rx LP

079196022

Products (2)

Diclofenac Sodium Delayed Release

71205-991

ANDA075185

ANDA (C73584)

ORAL

July 1, 2022

FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL 2000Inactive
Code: HAF0412YITClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Code: QTG126297QClass: ACTIBQuantity: 75 mg in 1 1

Diclofenac Sodium Delayed Release

71205-995

ANDA075185

ANDA (C73584)

ORAL

July 1, 2022

HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13Class: IACT
POLYETHYLENE GLYCOL 2000Inactive
Code: HAF0412YITClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
Code: QTG126297QClass: ACTIBQuantity: 50 mg in 1 1
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