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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

Effective Date
May 9, 2014
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.

Aphena Pharma Solutions - Tennessee, LLC

Aphena Pharma Solutions - Tennessee, LLC

128385585

Products2

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
43353-690
Application Number
ANDA090027
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 9, 2014
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Code: 7D7RX5A8MOClass: ACTIMQuantity: 75 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Venlafaxine Hydrochloride

Product Details

NDC Product Code
43353-689
Application Number
ANDA090027
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 9, 2014
Code: 7D7RX5A8MOClass: ACTIMQuantity: 37.5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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