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FDA Approval

venlafaxine hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
March 2, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Venlafaxine(75 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

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

venlafaxine hydrochloride

Product Details

NDC Product Code
50090-5145
Application Number
ANDA090174
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 6, 2020
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive
Code: P2OM2Q86BIClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
Code: 7D7RX5A8MOClass: ACTIMQuantity: 75 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
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