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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 218450

DIAZEPAM (DIAZEPAM)
10MG/2ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: DIAZEPAM
Proprietary Name: DIAZEPAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/2ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A218450
Product Number: 001
Approval Date: Apr 25, 2024
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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