.

BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

► See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Medtronic
Healthtrust
Cipla
Farmers Insurance
Daiichi Sankyo
Express Scripts
Teva
Merck
Federal Trade Commission
Mallinckrodt

Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090778

« Back to Dashboard
NDA 090778 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: 090778

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

Pharmacology for NDA: 090778

Suppliers and Packaging for NDA: 090778

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL 090778 ANDA KAISER FOUNDATION HOSPITALS 0179-0144 0179-0144-70 30 CAPSULE, DELAYED RELEASE in 1 BOX, UNIT-DOSE (0179-0144-70)
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL 090778 ANDA Mylan Institutional Inc. 42292-019 42292-019-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE (42292-019-20) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (42292-019-01)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 60MG BASE
Approval Date:Dec 11, 2013TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Chinese Patent Office
Daiichi Sankyo
US Army
Moodys
Baxter
Deloitte
Citi
Cantor Fitzgerald
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot