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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 Gland Pharma Ltd, Luitpold Pharms Inc, Sun Pharma Global, Hospira, Fresenius Kabi Usa, Mylan Labs Ltd, Actavis Inc, Cipla Ltd, Actavis Totowa, Emcure Pharms Ltd, Hameln Rds Gmbh, Dr Reddys Labs Ltd, Hospira Inc, Teva Pharms, Jiangsu Hansoh Pharm, Accord Hlthcare, Sagent Pharms, and Fresenius Kabi Oncol, and is included in twenty NDAs. It is available from sixteen suppliers. Additional details are available on the GEMCITABINE HYDROCHLORIDE profile page.

The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are twenty-seven drug master file entries for this compound. Seventeen suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

Summary for NDA: 202063

Emcure Pharms Ltd
gemcitabine hydrochloride
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
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
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

Summary for product number 001

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

Summary for product number 002

Approval Date:Sep 11, 2012TE:APRLD:No

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