Drug Approval Package
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Approval Package
Levothyroxine Sodium Tablets USP
0.025, 0.05, 0.075, 0.088, 0.1, 0.112,
0.125, 0.15, 0.175, 0.2 & 0.3 mg, Rx
Company: Mylan Pharmaceuticals Inc.
Application No.:ANDA 76-187
Approval Date: 6/5/2002
- Approval letter (PDF)
- Labeling (PDF)
- Bioequivalence Reviews (PDF)
- EES and Chemistry Reviews (PDF)
- Patent Exclusivity and Administrative Documents (PDF)
Date created: July 8, 2003; Page Last Updated: July 9, 2003
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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