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GEMCITABINE

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

Gemzar (gemcitabine HCl) for Injection, Eli Lilly NDA 20-509/S21 5/1/02 5/9/02 | Gemzar (gemcitabine HCl) for Injection, Eli Lilly NDA 20-509/S13 1/6/03 1/23/03 1/23/03 | Gemzar (gemcitabine HCl) for Injection, Eli Lilly NDA 20-509 SE1-005 8/26/98 8/28/98 8/28/98 | Gemzar Indications: For use in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer. Gemzar (gemcitabine HCl) for Injection, Eli Lilly and Company | Gemzar (gemcitabine HCl) for Injection, Eli Lilly and Co., Labeling Revision | Gemzar (gemcitabine HCl) Injection, Eli Lilly & Co., Efficacy Supplement w/Clinical Data | Gemzar (gemcitabine HCl) Injection, Eli Lilly, Labeling Revision | Gemcitabine Injection, Sicor Pharma, Tentative Approval | Gemcitabine Injection, Sicor Pharma, Tentative Approval | Gemcitabine Injection, Hospira Inc., Tentative Approval | Gemcitabine Injection, Sun Pharma, Tentative Approval | Gemcitabine Hydrochloride Injection, TEVA Parenteral Medicines, Inc., Approval | Gemcitabine Injection, Hospira, Inc., Tentative Approval | Gemcitabine Injection, APP Pharmaceuticals, LLC, Tentative Approval | Gemcitabine Injection, Teva Parenteral Medicines, Inc., Tentative Approval | Gemcitabine Injection, Watson Laboratories, Inc., Tentative Approval | Gemcitabine Injection, Actavis Totowa, LLC, Tentative Approval | Gemcitabine Injection, Pliva Lachema, Tentative Approval | Gemzar (gemcitabine hydrochloride) Injection, Eli Lilly and Co., Labeling Revision | Gemcitabine Injection, Hospira, Inc., Approval | Gemcitabine Injection, Teva Parenteral Medicines, Inc., Approval | Gemcitabine Injection, Fresenius Kabi Oncology Plc., Tentative Approval | Gemzar (gemcitabine hydrochloride) Injection, Eli Lily and Co., Labeling Revision | Gemcitabine Injection, Bedford Laboratories, Tentative Approval | Gemcitabine Injection, APP Pharmaceuticals, LLC, Approval | Gemcitabine Injection, Fresenius Kabi Oncology Plc., Approval | Gemcitabine Injection, B&H Consulting Services, Inc., Tentative Approval | Gemcitabine Hydrochloride Injection, Actavis Totowa LLC, Approval | Gemcitabine Hydrochloride Injection, Dr. Reddy's Laboratories Ltd., Approval | Gemcitabine Hydrochloride Injection, Fresenius Kabi Oncology Plc, Approval | Gemcitabine Hydrochloride Injection, Hospira, Inc., Approval | Gemcitabine Hydrochloride Injection, Onco Therapies Ltd., Approval | Gemcitabine Hydrochloride Injection, Sun Pharma Global FZE, Approval | Gemcitabine Hydrochloride Injection, Watson Laboratories, Inc., Approval | Gemcitabine Hydrochloride Injection, Accord Healthcare Inc., Approval | Gemcitabine Injection, Hospira, Inc., Approval | Gemcitabine, gemcitabine, Injectable; Injection, Hameln Rds Gmbh, Approval | Gemcitabine Hydrochloride, gemcitabine hydrochloride, Injectable; Injection, Emcure Pharms Ltd, Approval | Gemcitabine Hydrochloride, gemcitabine hydrochloride, Injectable; Injection, Hospira Inc, Manufacturing Change or Addition | Gemcitabine, gemcitabine hydrochloride, Injectable; Injection, Sagent Pharms, Tentative Approval | Gemcitabine Hydrochloride, gemcitabine hydrochloride, Injectable; Injection, Sagent Pharms, Approval | Gemcitabine Hydrochloride, gemcitabine hydrochloride, Injectable; Injection, Pharmaforce, Approval | Gemcitabine Hydrochloride, gemcitabine hydrochloride, Injectable; Injection, Jiangsu Hansoh Pharm, Approval | Gemcitabine Hydrochloride, gemcitabine hydrochloride, Injectable; Injection, Dr Reddys Labs Ltd, Approval | Gemzar, gemcitabine hydrochloride, Injectable; Injection, Lilly, Labeling Revision | Gemcitabine Hydrochloride, gemcitabine hydrochloride, Injectable; Injection, Hospira Inc, Manufacturing Change or Addition

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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