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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078581

TEMAZEPAM (TEMAZEPAM)
7.5MG
Marketing Status: Prescription
Active Ingredient: TEMAZEPAM
Proprietary Name: TEMAZEPAM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078581
Product Number: 001
Approval Date: Sep 8, 2009
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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