Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 217843

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DIAZEPAM (DIAZEPAM)
2MG
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: DIAZEPAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217843
Product Number: 001
Approval Date: Dec 14, 2023
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DIAZEPAM (DIAZEPAM)
5MG
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: DIAZEPAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217843
Product Number: 002
Approval Date: Dec 14, 2023
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DIAZEPAM (DIAZEPAM)
10MG
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: DIAZEPAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217843
Product Number: 003
Approval Date: Dec 14, 2023
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information