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GRANISETRON

 
 
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Drug Information
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Type 2 master files on file at the FDA

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Federal Register
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FDA Approved Labelling
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Title 21 Code of Federal Regulations
FDA regulations for this API

   

 


 

FDA Approval Activities for this Drug…

Kytril (granisetron HCL) Injection, Hoffmann-La Roche NDA 20-239/S8 8/16/02 8/21/02 8/20/02 Kytril (granisetron) Solution, Hoffmann-La Roche NDA 21-238 6/27/01 11/6/01 11/6/01 12/12/01 Kytril (granisetron) Tablets, SmithKline Beecham NDA 20-305/S-004 Kytril (granisetron) Injection, Hoffmann- LaRoche, Formulation Revision | Granisetron Hydrochloride Injection, Sicor Pharma, Tentative Approval | Granisetron Hydrochloride Injection, Sicor Pharma, Tentative Approval | Granisetron HCl Injection, Baxter Healthcare, Tentative Approval | Kytril (granisetron hydrochloride) Tablets, Hoffman-La Roche, Labeling Revision | Kytril (granisetron hydrochloride) Oral Solution, Hoffman-La Roche, Labeling Revision | Kytril (granisetron) Injection, Hoffman-La Roche, Labeling Revision | Granisetron Hydrochloride Injection, Bedford Labs, Tentative Approval | Granisetron Hydrochloride Tablets, Roxane Labs, Tentative Approval | Granisetron Hydrochloride Tablets, Barr Labs, Tentative Approval | Granisetron Hydrochloride Tablets, CorePharma, Tentative Approval | Granisetron Hydrochloride Injection, Abraxis Pharma, Tentative Approval | Granisetron Hydrochloride Injection, Watson Labs, Tentative Approval | Granisetron Hydrochloride Injection, Abraxis Pharma, Tentative Approval | Granisetron Hydrochloride Injection, Baxter Healthcare, Tentative Approval | Granisetron Hydrochloride Injection, Teva Parenteral, Tentative Approval | Granisetron Hydrochloride Tablet, Cipla Ltd., Tentative Approval | Granisetron Hydrochloride Injection, Watson Labs, Tentative Approval | Granisetron Hydrochloride Injection, Abraxis Pharma, Approval | Granisetron Hydrochloride Injection, Teva Parenteral, Tentative Approval | Granisetron Hydrochloride Injection, Abraxis Pharma, Tentative Approval | Granisetron Hydrochloride Injection, APP Pharma, Tentative Approval | Granisetron Hydrochloride Injection, Teva Parenteral, Approval | Granisetron Hydrochloride Injection, Apotex, Tentative Approval | Granisetron Hydrochloride Tablets, Mylan Pharma, Approval | Granisetron Hydrochloride Tablets, Orchid Healthcare, Approval | Granisetron Hydrochloride Tablets, Cipla Ltd., Approval | Granisetron Hydrochloride Tablets, Apotex, Approval | Granisetron Hydrochloride Injection, Wockhart, Approval | Granisetron Oral Solution, Cypress Pharma, Approval | Granisetron Hydrochloride Injection, Wockhardt, Tentative Approval | Granisetron Hydrochloride Injection, Ebewe Parenta, Approval | Granisetron Hydrochloride Injection, Wockhardt USA, Inc., Tentative Approval | Granisetron Hydrochloride Injection, Ebewe Pharmaceuticals, Inc., Tentative Approval | Granisetron Hydrochloride Injection, Bedford Laboratories, Approval | Granisetron Hydrochloride Injection, Apotex Corp., Approval | Granisetron Hydrochloride Injection, Abraxis Pharmaceutical Products, Approval | Granisetron Hydrochloride Injection, Bedford Laboratories, Approval | Granisetron Hydrochloride Injection, Dr. Reddy's Laboratories, Ltd., Approval | Granisetron Hydrochloride Injection, Ebewe Parenta Pharmaceuticals, Inc., Approval | Granisetron Hydrochloride Injection, Teva Parenteral Medicines, Inc., Approval | Granisetron Hydrochloride Injection, Watson Laboratories, Inc., Approval | Granisetron Hydrochloride Injection, Wockhardt USA, Inc., Approval | Sancuso (granisetron) Transdermal System, Strakan International, Ltd., Approval

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


 

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