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Last Updated: August 9, 2020

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Details for New Drug Application (NDA): 210991

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NDA 210991 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 210991
Tradename:GEMCITABINE HYDROCHLORIDE
Applicant:Shilpa Medicare Ltd
Ingredient:gemcitabine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/5.26ML (38MG/ML)
Approval Date:Oct 4, 2019TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/26.3ML (38MG/ML)
Approval Date:Oct 4, 2019TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/52.6ML (38MG/ML)
Approval Date:Oct 4, 2019TE:APRLD:No

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