MedPath
FDA Product

temazepam

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

Basic Information

temazepam

63629-8601

Regulatory Information

63629-8601

ANDA071457

C73584

December 30, 2020

USA

HUMAN PRESCRIPTION DRUG LABEL

105

Company Information

171714327

Active Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

TEMAZEPAM

Quantity: 7.5 mg in 1 1

Code: CHB1QD2QSS

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

Active Moieties

TEMAZEPAM

Code: CHB1QD2QSS

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