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Details for New Drug Application (NDA): 090728

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NDA 090728 describes DULOXETINE HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Ltd, Zydus Pharms Usa Inc, Inventia Hlthcare, Hetero Labs Ltd Iii, Apotex Inc, Sun Pharma Global, Alembic Pharms Ltd, Torrent Pharms Ltd, Actavis Elizabeth, Aurobindo Pharma Ltd, Anchen Pharms, Teva Pharms Usa, Breckenridge Pharm, Lupin Ltd, and Alkem Labs Ltd, and is included in sixteen NDAs. It is available from forty-one suppliers. Additional details are available on the DULOXETINE HYDROCHLORIDE profile page.

The generic ingredient in DULOXETINE HYDROCHLORIDE is duloxetine hydrochloride. There are forty-one drug master file entries for this compound. Fifty-one suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the duloxetine hydrochloride profile page.

Summary for NDA: 090728

Tradename:
DULOXETINE HYDROCHLORIDE
Applicant:
Zydus Pharms Usa Inc
Ingredient:
duloxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 090728

Suppliers and Packaging for NDA: 090728

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL 090728 ANDA Cadila Healthcare Limited 65841-774 65841-774-06 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-774-06)
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL 090728 ANDA Cadila Healthcare Limited 65841-774 65841-774-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-774-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Jan 8, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 30MG BASE
Approval Date:Jan 8, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 60MG BASE
Approval Date:Jan 8, 2014TE:ABRLD:No


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