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FLUTAMIDE

 
 
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Drug Information
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Type 2 master files on file at the FDA

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For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

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

Research Links
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Title 21 Code of Federal Regulations
FDA regulations for this API

   

 


 

FDA Approval Activities for this Drug…

Eulexin (flutamide) Capsules, USP. Schering NDA 18-554/S-021 3/23/01 5/1/01 Eulexin (flutamide) Capsules, USP. Schering NDA 18-554/S-022 Flutamide Capsules USP, 125 mg, Barr, ANDA 75-820 9/18/01 4/15/03 Flutamide Capsules USP, 125 mg, Genpharm, ANDA 76-224 5/9/03 Flutamide Capsules USP, 125 mg, Eon Labs Manufacturing, ANDA 75-818 9/18/01 4/15/03 Flutamide Capsules USP, 125 mg, Eon Labs Manfacturing, ANDA 75-818 3/26/01 3/30/01 Flutamide Capsules USP, 125 mg, Zenith Goldline ANDA 75-780 9/19/01 4/15/03 Flutamide Capsules USP, 125 mg, Teva USA ANDA 75-298 9/18/01 4/11/03 Flutamide Capsules USP, 125 mg, Teva USA ANDA 75-298 3/23/01 3/30/01 FLUTAMIDE Capsule; 125MG FLUTAMIDE Barr 075818 FLUTAMIDE Capsule; 125MG FLUTAMIDE Eon 076224 FLUTAMIDE Capsule; 125MG FLUTAMIDE Genpharm 075780 FLUTAMIDE Capsule; 125MG FLUTAMIDE Ivax 018554 FLUTAMIDE Capsule; 125MG EULEXIN SCHERING 075298 FLUTAMIDE Capsule; 125MG FLUTAMIDE Teva

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


 

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