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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 076934


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NDA 076934 describes SERTRALINE HYDROCHLORIDE, which is a drug marketed by Almatica, ACI, Aurobindo Pharma, Ranbaxy Labs Ltd, Accord Hlthcare, Anda Repository, Ascent Pharms Inc, Chartwell Molecular, Fosun Pharma, Granules, Heritage Pharma Avet, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan, Mylan Pharms Inc, Oxford Pharms, Reyoung, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, Viwit Pharm, and Zydus, and is included in thirty-one NDAs. It is available from forty-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. Forty-seven suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
Summary for 076934
Tradename:SERTRALINE HYDROCHLORIDE
Applicant:Aci
Ingredient:sertraline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076934
Medical Subject Heading (MeSH) Categories for 076934
Suppliers and Packaging for NDA: 076934
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SERTRALINE HYDROCHLORIDE sertraline hydrochloride CONCENTRATE;ORAL 076934 ANDA Bryant Ranch Prepack 63629-8774 63629-8774-1 1 BOTTLE, DROPPER in 1 CARTON (63629-8774-1) / 60 mL in 1 BOTTLE, DROPPER
SERTRALINE HYDROCHLORIDE sertraline hydrochloride CONCENTRATE;ORAL 076934 ANDA ACI Healthcare USA, Inc. 71093-143 71093-143-11 1 BOTTLE, DROPPER in 1 CARTON (71093-143-11) / 60 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrengthEQ 20MG BASE/ML
Approval Date:Jun 30, 2006TE:AARLD:No

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