MedPath
FDA Product

Celecoxib

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

Basic Information

Celecoxib

71209-056

Regulatory Information

71209-056

ANDA208701

C73584

December 8, 2022

USA

These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

Human Prescription Drug Label

13

Company Information

862257719

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

CELECOXIB

Quantity: 200 mg in 1 1

Code: JCX84Q7J1L

Class Code: ACTIB

GELATIN

Code: 2G86QN327L

Class Code: IACT

SHELLAC

Code: MB5IUD6JUA

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

CELECOXIB

Code: JCX84Q7J1L

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