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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204170

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ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
6.25MG
Marketing Status: Prescription
Active Ingredient: ZOLPIDEM TARTRATE
Proprietary Name: ZOLPIDEM TARTRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 6.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204170
Product Number: 001
Approval Date: Jan 24, 2017
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
12.5MG
Marketing Status: Prescription
Active Ingredient: ZOLPIDEM TARTRATE
Proprietary Name: ZOLPIDEM TARTRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204170
Product Number: 002
Approval Date: Jan 24, 2017
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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