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Generated: May 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204520

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NDA 204520 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-eight 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 NDA: 204520

Formulation / Manufacturing:see details

Pharmacology for NDA: 204520

Suppliers and Packaging for NDA: 204520

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
gemcitabine hydrochloride
INJECTABLE;INJECTION 204520 ANDA Gland Pharma Limited 68083-148 68083-148-01 1 VIAL in 1 CARTON (68083-148-01) > 5 mL in 1 VIAL
gemcitabine hydrochloride
INJECTABLE;INJECTION 204520 ANDA Gland Pharma Limited 68083-149 68083-149-01 1 VIAL in 1 CARTON (68083-149-01) > 25 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:Jan 5, 2016TE:APRLD:No

Summary for product number 002

Approval Date:Jan 5, 2016TE:APRLD:No

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