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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021144

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KETEK (TELITHROMYCIN)
300MG
Marketing Status: Discontinued
Active Ingredient: TELITHROMYCIN
Proprietary Name: KETEK
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021144
Product Number: 002
Approval Date: Feb 9, 2005
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
KETEK (TELITHROMYCIN)
400MG
Marketing Status: Discontinued
Active Ingredient: TELITHROMYCIN
Proprietary Name: KETEK
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021144
Product Number: 001
Approval Date: Apr 1, 2004
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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