Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090723

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NDA 090723 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, Cspc Ouyi, Hetero Labs Ltd Iii, Inventia, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Prinston Inc, Qingdao Baheal Pharm, Sun Pharm, Teva Pharms Usa, Torrent, Yaopharma Co Ltd, Zydus Hlthcare, and Zydus Pharms, and is included in twenty-two 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-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 090723
Tradename:DULOXETINE HYDROCHLORIDE
Applicant:Marksans Pharma
Ingredient:duloxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090723
Suppliers and Packaging for NDA: 090723
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090723 ANDA Medsource Pharmaceuticals 45865-813 45865-813-30 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (45865-813-30)
DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090723 ANDA Medsource Pharmaceuticals 45865-813 45865-813-60 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (45865-813-60)

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 60MG BASE
Approval Date:Dec 11, 2013TE:ABRLD:No

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