Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021412

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TOVALT ODT (ZOLPIDEM TARTRATE)
5MG
Marketing Status: Discontinued
Active Ingredient: ZOLPIDEM TARTRATE
Proprietary Name: TOVALT ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021412
Product Number: 001
Approval Date: Apr 25, 2007
Applicant Holder Full Name: BIOVAIL LABORATORIES INTERNATIONAL SRL
Marketing Status:  Discontinued
Patent and Exclusivity Information
TOVALT ODT (ZOLPIDEM TARTRATE)
10MG
Marketing Status: Discontinued
Active Ingredient: ZOLPIDEM TARTRATE
Proprietary Name: TOVALT ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021412
Product Number: 002
Approval Date: Apr 25, 2007
Applicant Holder Full Name: BIOVAIL LABORATORIES INTERNATIONAL SRL
Marketing Status:  Discontinued
Patent and Exclusivity Information

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