.

Make Better Decisions

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

► 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:

Cerilliant
Julphar
AstraZeneca
McKesson
Fish and Richardson
Boehringer Ingelheim
US Department of Justice
McKinsey
Chubb
Daiichi Sankyo

Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076015

« Back to Dashboard
NDA 076015 describes FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Teva Pharms Usa, Barr, Teva, Dr Reddys Labs Inc, Mylan, Sandoz, Aurobindo Pharma Ltd, Wockhardt, Pharm Assoc, Aurobindo Pharma, Mallinckrodt, Carlsbad, Par Pharm, Alembic Pharms Ltd, Hi Tech Pharma, Alvogen, Heritage Pharms Inc, Par Form, Torrent Pharms Ltd, Wockhardt Ltd, Ivax Sub Teva Pharms, Silarx, Lannett, Landela Pharm, Cr Double Crane, Dr Reddys Labs Ltd, Mylan Pharms Inc, Ani Pharms Inc, Sun Pharm Inds Ltd, Actavis Mid Atlantic, Apotex Inc, and Sciegen Pharms Inc, and is included in forty-six NDAs. It is available from sixty-eight suppliers. Additional details are available on the FLUOXETINE HYDROCHLORIDE profile page.

The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for NDA: 076015

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

Pharmacology for NDA: 076015

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 076015

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
SOLUTION;ORAL 076015 ANDA Pharmaceutical Associates, Inc. 0121-0721 0121-0721-04 120 mL in 1 BOTTLE (0121-0721-04)
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
SOLUTION;ORAL 076015 ANDA Pharmaceutical Associates, Inc. 0121-4721 0121-4721-40 4 TRAY in 1 CASE (0121-4721-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-4721-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 20MG BASE/5ML
Approval Date:Jan 30, 2002TE:AARLD: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:

Mallinckrodt
QuintilesIMS
McKesson
Farmers Insurance
Fuji
AstraZeneca
Moodys
Daiichi Sankyo
Accenture
Baxter

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