MedPath
FDA Product

PREGABALIN

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

Basic Information

PREGABALIN

72189-045

Regulatory Information

72189-045

ANDA209743

C73584

July 5, 2023

USA

PREGABALIN

HUMAN PRESCRIPTION DRUG LABEL

12

Company Information

Direct_Rx

079254320

Active Ingredients

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

PREGABALIN

Quantity: 225 mg in 1 1

Code: 55JG375S6M

Class Code: ACTIB

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

Active Moieties

PREGABALIN

Code: 55JG375S6M

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