Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077322

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ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
5MG
Marketing Status: Prescription

Active Ingredient: ZOLPIDEM TARTRATE
Proprietary Name: ZOLPIDEM TARTRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077322
Product Number: 001
Approval Date: Apr 23, 2007
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
10MG
Marketing Status: Prescription

Active Ingredient: ZOLPIDEM TARTRATE
Proprietary Name: ZOLPIDEM TARTRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077322
Product Number: 002
Approval Date: Apr 23, 2007
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information