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Last Updated: November 14, 2024

Details for New Drug Application (NDA): 205242


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NDA 205242 describes GEMCITABINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Am Regent, Apotex, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hameln Rds Gmbh, Hikma, Hikma Intl Pharms, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Norvium Bioscience, Novast Labs, Sagent Pharms, Sagent Pharms Inc, Shilpa, Sun Pharm, Teva Pharms, and Teyro Labs, and is included in thirty NDAs. It is available from thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 205242
Tradename:GEMCITABINE HYDROCHLORIDE
Applicant:Mylan Labs Ltd
Ingredient:gemcitabine hydrochloride
Patents:0
Pharmacology for NDA: 205242
Suppliers and Packaging for NDA: 205242
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 205242 ANDA Mylan Institutional LLC 67457-616 67457-616-10 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-616-10) / 5.26 mL in 1 VIAL, SINGLE-DOSE
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 205242 ANDA Mylan Institutional LLC 67457-617 67457-617-30 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-617-30) / 26.3 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/5.26ML (38MG/ML)
Approval Date:Dec 6, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/26.3ML (38MG/ML)
Approval Date:Dec 6, 2017TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/52.6ML (38MG/ML)
Approval Date:Dec 6, 2017TE:APRLD:No

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