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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

Zydus Lifesciences Limited

DUNS: 918596198

Effective Date

September 28, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Venlafaxine(150 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Zydus Lifesciences Limited

DUNS Number

918596198

Manufacturing Establishments1

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

Zydus Lifesciences Limited

Labeler

Zydus Lifesciences Limited

Registrant

Zydus Lifesciences Limited

DUNS Number

918596198

Products3

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

65841-753

Application Number

ANDA090174

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 28, 2023

Ingredients

VenlafaxineActive

Code: 7D7RX5A8MOClass: ACTIMQuantity: 150 mg in 1 1

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CETOSTEARYL ALCOHOLInactive

Code: 2DMT128M1SClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive

Code: P2OM2Q86BIClass: IACT

venlafaxine hydrochloride

Product Details

NDC Product Code

65841-752

Application Number

ANDA090174

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 28, 2023

Ingredients

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

VenlafaxineActive

Code: 7D7RX5A8MOClass: ACTIMQuantity: 75 mg in 1 1

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive

Code: P2OM2Q86BIClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

CETOSTEARYL ALCOHOLInactive

Code: 2DMT128M1SClass: IACT

venlafaxine hydrochloride

Product Details

NDC Product Code

65841-751

Application Number

ANDA090174

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 28, 2023

Ingredients

VenlafaxineActive

Code: 7D7RX5A8MOClass: ACTIMQuantity: 37.5 mg in 1 1

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

CETOSTEARYL ALCOHOLInactive

Code: 2DMT128M1SClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive

Code: P2OM2Q86BIClass: IACT

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