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Serving leading biopharmaceutical companies globally:

UBS
Cerilliant
Queensland Health
AstraZeneca
Teva
Novartis
Healthtrust
Johnson and Johnson
Express Scripts
Daiichi Sankyo

Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203197

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NDA 203197 describes DULOXETINE HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Macleods Pharms Ltd, Dr Reddys Labs Ltd, Zydus Pharms Usa Inc, Inventia Hlthcare, Zydus Hlthcare, Hetero Labs Ltd Iii, Apotex Inc, Sun Pharma Global, Alembic Pharms Ltd, Prinston Inc, 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 nineteen NDAs. It is available from forty-five 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-five suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.

Summary for NDA: 203197

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

Pharmacology for NDA: 203197

Suppliers and Packaging for NDA: 203197

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL 203197 ANDA Ascend Laboratories, LLC 67877-263 67877-263-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-263-01)
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL 203197 ANDA Ascend Laboratories, LLC 67877-263 67877-263-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-263-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Aug 26, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 30MG BASE
Approval Date:Aug 26, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 60MG BASE
Approval Date:Aug 26, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Deloitte
Fish and Richardson
Accenture
Cipla
Cerilliant
Argus Health
Dow
Johnson and Johnson
UBS

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