Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 070311

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DIAZEPAM (DIAZEPAM)
50MG/10ML (5MG/ML)
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: DIAZEPAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/10ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A070311
Product Number: 001
Approval Date: Dec 16, 1985
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DIAZEPAM (DIAZEPAM)
5MG/ML (5MG/ML)
Marketing Status: Discontinued

Active Ingredient: DIAZEPAM
Proprietary Name: DIAZEPAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A070311
Product Number: 002
Approval Date: Dec 16, 1985
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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

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: 
Application Number: A070311
Product Number: 003
Approval Date: Dec 16, 1985
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information