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GEMTUZUMAB

 
 
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…

Mylotarg (Gemtuzumab Ozogamicin) Injection, Wyeth-Ayerst NDA 21-174/S-002 2/23/01 4/23/03 Mylotarg (Gemtuzumab Ozogamicin) Injection, Wyeth-Ayerst NDA 21-174 5/17/00 5/22/00 5/22/00 6/4/01 Mylotarg Indication: for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy. Mylotarg (Gemtuzumab Ozogamicin) Injection, Wyeth Pharmaceuticals Mylotarg (gemtuzumab ozogamicin) for Injection, Wyeth Pharmaceuticals 21-174/S-012,-014 Mylotarg (gemtuzumab ozogamicin) for Injection, Wyeth Pharmaceuticals, Package Change | Mylotarg (gemtuzumab ozogamicin) Injection, Wyeth Pharma, Labeling Revision | Mylotarg (gemutuzumab ozogamicin) Injection, Wyeth Pharma, Labeling Revision | Mylotarg (gemtuzumab ozogamicin) Injection, Wyeth Pharma, Efficacy Sup w/Clinical Data

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

                                                                   

 

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