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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090694

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NDA 090694 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-three 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. Forty-eight suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 090694
Tradename:DULOXETINE HYDROCHLORIDE
Applicant:Lupin Ltd
Ingredient:duloxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 090694
Suppliers and Packaging for NDA: 090694
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090694 ANDA LUPIN PHARMA 27437-298 N 27437-298-06
DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090694 ANDA REMEDYREPACK INC. 52125-924 N 52125-924-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Dec 11, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 30MG BASE
Approval Date:Dec 11, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 40MG BASE
Approval Date:Dec 11, 2013TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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