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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
Argus Health
Dow
Novartis
Teva
Citi
Cerilliant
Express Scripts
Baxter

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078861

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NDA 078861 describes SERTRALINE HYDROCHLORIDE, which is a drug marketed by Allied Pharma Inc, Aurobindo Pharma, Ranbaxy Labs Ltd, Accord Hlthcare, Aci Healthcare Ltd, Actavis Elizabeth, Anda Repository, Apotex Inc, Austarpharma Llc, Cipla Ltd, Dr Reddys Labs Ltd, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan, Mylan Pharms Inc, Oxford Pharms, Pliva Hrvatska Doo, Sandoz, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Torrent Pharms, Watson Labs Teva, Wockhardt, and Zydus Pharms Usa, and is included in twenty-nine NDAs. It is available from fifty-five 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. Sixty-one suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.

Summary for 078861

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

Pharmacology for NDA: 078861

Mechanism of ActionSerotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 078861

Suppliers and Packaging for NDA: 078861

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SERTRALINE HYDROCHLORIDE sertraline hydrochloride CONCENTRATE;ORAL 078861 ANDA NorthStar Rx LLC 16714-601 16714-601-02 1 BOTTLE, PLASTIC in 1 CARTON (16714-601-02) > 60 mL in 1 BOTTLE, PLASTIC
SERTRALINE HYDROCHLORIDE sertraline hydrochloride CONCENTRATE;ORAL 078861 ANDA NorthStar Rx LLC 16714-601 16714-601-01 1 BOTTLE in 1 CARTON (16714-601-01) > 60 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrengthEQ 20MG BASE/ML
Approval Date:Oct 31, 2008TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Argus Health
Medtronic
US Department of Justice
Healthtrust
Merck
UBS
Colorcon
Express Scripts
McKinsey

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.

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