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Details for New Drug Application (NDA): 078861

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

Summary for NDA: 078861

Tradename:
SERTRALINE HYDROCHLORIDE
Applicant:
Aurobindo Pharma
Ingredient:
sertraline hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details

Pharmacology for NDA: 078861

Mechanism of ActionSerotonin Uptake Inhibitors

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 16714-601-01 1 BOTTLE in 1 CARTON (16714-601-01) > 60 mL in 1 BOTTLE
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

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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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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