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FDA Product

Diclofenac Sodium Delayed Release

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Diclofenac Sodium Delayed Release

53002-5370

Regulatory Information

53002-5370

ANDA075185

C73584

July 14, 2017

USA

Diclofenac Sodium

HUMAN PRESCRIPTION DRUG LABEL

7

Company Information

147096275

Active Ingredients

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)

Code: 74G4R6TH13

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

POLYETHYLENE GLYCOL 2000

Code: HAF0412YIT

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

DICLOFENAC SODIUM

Quantity: 50 mg in 1 1

Code: QTG126297Q

Class Code: ACTIB

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

DICLOFENAC

Code: 144O8QL0L1

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