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AMIFOSTINE

 
 
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…

ETHYOL (amifostine) Injection, MedImmune Oncology, NDA 20-221/S-017 3/27/03 4/15/03 4/1/03 ETHYOL (amifostine) Injection, MedImmune Oncology, NDA 20-221/S-015 2/20/02 2/21/02 ETHYOL (amifostine) Injection, 500mg (amifostine anhydrous base), US Bioscience NDA 20-221/S-012 6/24/99 6/25/99 6/25/99 6/22/01 Ethyol Indication: To reduce the incidence of moderate to severe xerostomia in patients undergoing post-ooperative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands (see Clinical Studies). | Ethyol (amifostine) Injection, MedImmune Oncology, Labeling Revision | Amifostine Injection, Sun Pharma, Tentative Approval | Amifostine Injection, Sun Pharma, Approval | Ethyol (amifostine) Injection, MedImmune, Labeling Revision

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