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FDA Product

Fenoprofen Calcium

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

Basic Information

Fenoprofen Calcium

50090-3572

Regulatory Information

50090-3572

NDA017604

C73605

November 29, 2017

USA

These highlights do not include all the information needed to use Fenoprofen Calcium Capsules, USP safely and effectively. See full prescribing information for Fenoprofen Calcium Capsules, USP. Fenoprofen Calcium Capsules, USP for oral use Initial U.S. Approval: 1982

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

830016429

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CROSPOVIDONE, UNSPECIFIED

Code: 2S7830E561

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

FENOPROFEN CALCIUM

Quantity: 400 mg in 1 1

Code: 0X2CW1QABJ

Class Code: ACTIM

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

Active Moieties

FENOPROFEN

Code: RA33EAC7KY

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