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FDA Product

venlafaxine hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

venlafaxine hydrochloride

16714-043

Regulatory Information

16714-043

ANDA090174

C73584

June 20, 2023

USA

These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES.VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE capsules, for oral useInitial U.S. Approval: 1997

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

Northstar Rx LLC.

830546433

Active Ingredients

VENLAFAXINE HYDROCHLORIDE

Quantity: 37.5 mg in 1 1

Code: 7D7RX5A8MO

Class Code: ACTIM

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CETOSTEARYL ALCOHOL

Code: 2DMT128M1S

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

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

Code: P2OM2Q86BI

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

Active Moieties

VENLAFAXINE

Code: GRZ5RCB1QG

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