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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203088

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NDA 203088 describes DULOXETINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Anchen Pharms, Apotex Inc, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Inventia Hlthcare, Lupin Ltd, Macleods Pharms Ltd, Prinston Inc, Sun Pharma Global, Teva Pharms Usa, Torrent Pharms Ltd, Zydus Hlthcare, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from forty-four 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-four suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.

Summary for 203088

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 203088

Suppliers and Packaging for NDA: 203088

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 203088 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-025 43353-025-30 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-30)
DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 203088 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-025 43353-025-60 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Jun 11, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 30MG BASE
Approval Date:Jun 11, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 60MG BASE
Approval Date:Jun 11, 2014TE:ABRLD:No


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