MedPath
FDA Product

Alprazolam

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

Basic Information

Alprazolam

42254-216

Regulatory Information

42254-216

ANDA090082

C73584

June 18, 2010

USA

Alprazolam Tablets, USP CIV

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

118802834

Active Ingredients

ALPRAZOLAM

Quantity: 1 mg in 1 1

Code: YU55MQ3IZY

Class Code: ACTIB

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

DOCUSATE SODIUM

Code: F05Q2T2JA0

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

Active Moieties

ALPRAZOLAM

Code: YU55MQ3IZY

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