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Generated: November 22, 2017

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Details for New Drug Application (NDA): 202485

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NDA 202485 describes GEMCITABINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, 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, Apotex Inc, Hospira Inc, Teva Pharms, Jiangsu Hansoh Pharm, Sagent Pharms, and Fresenius Kabi Oncol, and is included in twenty-two NDAs. It is available from seventeen suppliers. Additional details are available on the GEMCITABINE HYDROCHLORIDE profile page.

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

Summary for 202485

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 202485

Suppliers and Packaging for NDA: 202485

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION 202485 ANDA Sagent Pharmaceuticals 25021-234 25021-234-10 1 VIAL in 1 CARTON (25021-234-10) > 5 mL in 1 VIAL
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION 202485 ANDA Sagent Pharmaceuticals 25021-235 25021-235-50 1 VIAL in 1 CARTON (25021-235-50) > 25 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:May 7, 2013TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:May 7, 2013TE:APRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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