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Venlafaxine Hydrochloride

Venlafaxine Hydrochloride Tablets

Approved
Approval ID

04c95282-2e10-4ab5-baf2-62d44dd8f22f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 30, 2011

Manufacturers
FDA

H.J. Harkins Company, Inc.

DUNS: 147681894

Products 1

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

Venlafaxine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52959-890
Application NumberANDA077653
Product Classification
M
Marketing Category
C73584
G
Generic Name
Venlafaxine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2011
FDA Product Classification

INGREDIENTS (7)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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Venlafaxine Hydrochloride - FDA Drug Approval Details