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FDA Product

Fenoprofen Calcium

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

Basic Information

Fenoprofen Calcium

42195-471

Regulatory Information

42195-471

ANDA072267

C73584

October 13, 2023

USA

Fenoprofen Calcium

HUMAN PRESCRIPTION DRUG LABEL

7

Company Information

Xspire Pharma, Llc

078312042

Active Ingredients

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

FENOPROFEN CALCIUM

Quantity: 600 mg in 1 1

Code: 0X2CW1QABJ

Class Code: ACTIM

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

Active Moieties

FENOPROFEN

Code: RA33EAC7KY

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