Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021774

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AMBIEN CR (ZOLPIDEM TARTRATE)
6.25MG Marketing Status: Prescription

Active Ingredient: ZOLPIDEM TARTRATE
Proprietary Name: AMBIEN CR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 6.25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021774
Product Number: 002
Approval Date: Sep 2, 2005
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

AMBIEN CR (ZOLPIDEM TARTRATE)
12.5MG Marketing Status: Prescription

Active Ingredient: ZOLPIDEM TARTRATE
Proprietary Name: AMBIEN CR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021774
Product Number: 001
Approval Date: Sep 2, 2005
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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