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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215721

ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
7.5MG
Marketing Status: Prescription
Active Ingredient: ZOLPIDEM TARTRATE
Proprietary Name: ZOLPIDEM TARTRATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 7.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215721
Product Number: 001
Approval Date: May 9, 2023
Applicant Holder Full Name: ALMATICA PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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