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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
US Department of Justice
Chubb
Boehringer Ingelheim
Colorcon
Express Scripts
Covington
AstraZeneca
Cerilliant
Cantor Fitzgerald

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090728

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NDA 090728 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 090728

Tradename:1
Applicant:1
Ingredient:1
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 65841-774-14 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-774-14)
DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090728 ANDA Cadila Healthcare Limited 65841-774 65841-774-16 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-774-16)

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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Serving leading biopharmaceutical companies globally:

Covington
Healthtrust
Julphar
Moodys
Teva
Harvard Business School
Colorcon
McKesson
Express Scripts
US Army

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