MedPath
FDA Product

Zorvolex

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

Basic Information

Zorvolex

42211-203

Regulatory Information

42211-203

NDA204592

C73594

May 18, 2016

USA

These highlights do not include all the information needed to use ZORVOLEX safely and effectively. See full prescribing information for ZORVOLEX. ZORVOLEX (diclofenac) capsules, for oral useInitial U.S. Approval: 1988

HUMAN PRESCRIPTION DRUG LABEL

7

Company Information

796831217

Active Ingredients

DICLOFENAC

Quantity: 18 mg in 1 1

Code: 144O8QL0L1

Class Code: ACTIB

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

DICLOFENAC

Code: 144O8QL0L1

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