MedPath
FDA Product

Celecoxib

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

Basic Information

Celecoxib

72189-360

Regulatory Information

72189-360

ANDA205129

C73584

June 8, 2022

USA

Celecoxib

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

DirectRx

079254320

Active Ingredients

CELECOXIB

Quantity: 200 mg in 1 1

Code: JCX84Q7J1L

Class Code: ACTIB

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

Active Moieties

CELECOXIB

Code: JCX84Q7J1L

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