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Last Updated: August 4, 2020

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Details for New Drug Application (NDA): 077670

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NDA 077670 describes SERTRALINE HYDROCHLORIDE, which is a drug marketed by Aci Healthcare Ltd, Aurobindo Pharma, Ranbaxy Labs Ltd, Accord Hlthcare, Anda Repository, Austarpharma Llc, Cadila, Chartwell Molecular, Fosun Pharma, Heritage Pharma, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan, Mylan Pharms Inc, Oxford Pharms, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, Viwit Pharm, and Wockhardt, and is included in twenty-nine NDAs. It is available from thirty-seven 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
Summary for 077670
Tradename:SERTRALINE HYDROCHLORIDE
Applicant:Lupin
Ingredient:sertraline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077670
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 077670
Suppliers and Packaging for NDA: 077670
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077670 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7989 0615-7989-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7989-05)
SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077670 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7989 0615-7989-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7989-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Feb 6, 2007TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Express Scripts
Harvard Business School
Baxter
McKesson

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