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Venlafaxine

Venlafaxine Tablets, USP

Approved
Approval ID

017a84aa-0e1f-f560-e063-6294a90a9069

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 27, 2023

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

Products 1

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

Venlafaxine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68071-3431
Application NumberANDA077653
Product Classification
M
Marketing Category
C73584
G
Generic Name
Venlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2023
FDA Product Classification

INGREDIENTS (7)

FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM

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Venlafaxine - FDA Drug Approval Details