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Last Updated: August 11, 2020

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Details for New Drug Application (NDA): 202063

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NDA 202063 describes GEMCITABINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Am Regent, Apotex, Cipla, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hameln Rds Gmbh, Hospira, Hospira Inc, Ingenus Pharms Llc, Jiangsu Hansoh Pharm, Mylan Labs Ltd, Sagent Pharms, Sagent Pharms Inc, Shilpa Medicare Ltd, Sun Pharm, and Teva Pharms, and is included in twenty-seven NDAs. It is available from fifteen suppliers. Additional details are available on the GEMCITABINE HYDROCHLORIDE profile page.

The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 202063
Tradename:GEMCITABINE HYDROCHLORIDE
Applicant:Emcure Pharms Ltd
Ingredient:gemcitabine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202063
Suppliers and Packaging for NDA: 202063
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 202063 ANDA Heritage Pharmaceuticals Inc. 23155-213 23155-213-31 1 VIAL, GLASS in 1 CARTON (23155-213-31) > 5 mL in 1 VIAL, GLASS
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 202063 ANDA Heritage Pharmaceuticals Inc. 23155-214 23155-214-31 1 VIAL, GLASS in 1 CARTON (23155-214-31) > 25 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:Sep 11, 2012TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Sep 11, 2012TE:APRLD:No

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