MedPath
FDA Product

Pregabalin

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

Basic Information

Pregabalin

60219-1315

Regulatory Information

60219-1315

ANDA209743

C73584

August 16, 2021

USA

These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use CV Initial U.S. Approval: 2004

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

123797875

Active Ingredients

PREGABALIN

Quantity: 200 mg in 1 1

Code: 55JG375S6M

Class Code: ACTIB

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

PREGABALIN

Code: 55JG375S6M

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