Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091076

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DIAZEPAM (DIAZEPAM)
10MG/2ML (5MG/ML)
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: DIAZEPAM
Dosage Form; Route of Administration: GEL; RECTAL
Strength: 10MG/2ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091076
Product Number: 001
Approval Date: May 30, 2023
Applicant Holder Full Name: NOVEL LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DIAZEPAM (DIAZEPAM)
20MG/4ML (5MG/ML)
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: DIAZEPAM
Dosage Form; Route of Administration: GEL; RECTAL
Strength: 20MG/4ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091076
Product Number: 002
Approval Date: May 30, 2023
Applicant Holder Full Name: NOVEL LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information