.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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

Serving leading biopharmaceutical companies globally:

Covington
Cantor Fitzgerald
Fuji
Dow
McKesson
Argus Health
Deloitte
QuintilesIMS
Healthtrust
Farmers Insurance

Generated: November 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077397

« Back to Dashboard
NDA 077397 describes SERTRALINE HYDROCHLORIDE, which is a drug marketed by Wockhardt, Aurobindo Pharma, Zydus Pharms Usa, Sun Pharm Inds (in), Sandoz, Anda Repository, Ivax Sub Teva Pharms, Accord Hlthcare, Mylan Pharms Inc, Allied Pharma Inc, Dr Reddys Labs Ltd, Actavis Elizabeth, Ranbaxy Labs Ltd, Cipla Ltd, Watson Labs Teva, Hikma Pharms, Teva, Torrent Pharms, Lupin, Mylan, Oxford Pharms, Austarpharma Llc, Sun Pharm Inds Ltd, Aci Healthcare Ltd, Apotex Inc, Invagen Pharms, and Pliva Hrvatska Doo, and is included in twenty-nine NDAs. It is available from fifty-three suppliers. Additional details are available on the SERTRALINE HYDROCHLORIDE profile page.

The generic ingredient in SERTRALINE HYDROCHLORIDE is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.

Summary for 077397

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

Pharmacology for NDA: 077397

Mechanism of ActionSerotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 077397

Suppliers and Packaging for NDA: 077397

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL 077397 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6558 0615-6558-05 15 TABLET in 1 BLISTER PACK (0615-6558-05)
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL 077397 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6558 0615-6558-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-6558-30) > 5 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Feb 6, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Feb 6, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Feb 6, 2007TE: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 leading biopharmaceutical companies globally:

US Army
Healthtrust
Fuji
Express Scripts
Cipla
AstraZeneca
Queensland Health
McKesson
Boehringer Ingelheim
Medtronic

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
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot