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Details for New Drug Application (NDA): 078554

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NDA 078554 describes VENLAFAXINE HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Ltd, Osmotica Pharm, Sandoz, Pliva Hrvatska Doo, Orchid Hlthcare, Sun Pharm Inds Inc, Vintage, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Yaopharma Co Ltd, Zydus Pharms Usa, Heritage Pharms Inc, Aurobindo Pharma, Teva, Wockhardt, Mylan, Valeant Pharms North, Sun Pharma Global, Zydus Pharms Usa Inc, Anchen Pharms, Amneal Pharms, and Torrent Pharms Llc, and is included in twenty-five NDAs. It is available from sixty-six suppliers. There are two patents protecting this drug. Additional details are available on the VENLAFAXINE HYDROCHLORIDE profile page.

The generic ingredient in VENLAFAXINE HYDROCHLORIDE is venlafaxine hydrochloride. There are sixty-eight drug master file entries for this compound. Seventy-two suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the venlafaxine hydrochloride profile page.

Summary for NDA: 078554

Tradename:
VENLAFAXINE HYDROCHLORIDE
Applicant:
Heritage Pharms Inc
Ingredient:
venlafaxine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 078554

Suppliers and Packaging for NDA: 078554

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL 078554 ANDA KAISER FOUNDATION HOSPITALS 0179-0157 0179-0157-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0157-70)
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL 078554 ANDA KAISER FOUNDATION HOSPITALS 0179-0158 0179-0158-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0158-70)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Jan 9, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 37.5MG BASE
Approval Date:Jan 9, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Jan 9, 2009TE:ABRLD:No


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