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Alprazolam

Alprazolam Tablets

Approved
Approval ID

041ae7f6-7e42-4803-a015-f3bfcce277ba

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 9, 2011

Manufacturers
FDA

RedPharm Drug Inc.

DUNS: 008039641

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Alprazolam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67296-0431
Application NumberANDA074112
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2011
FDA Product Classification

INGREDIENTS (7)

AlprazolamActive
Quantity: .25 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
docusate sodiumInactive
Code: F05Q2T2JA0
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT

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Alprazolam - FDA Drug Approval Details