Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215000

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CARMUSTINE (CARMUSTINE)
50MG/VIAL
Marketing Status: Prescription

Active Ingredient: CARMUSTINE
Proprietary Name: CARMUSTINE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 50MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215000
Product Number: 001
Approval Date: May 16, 2022
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CARMUSTINE (CARMUSTINE)
300MG/VIAL
Marketing Status: Prescription

Active Ingredient: CARMUSTINE
Proprietary Name: CARMUSTINE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 300MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215000
Product Number: 002
Approval Date: May 16, 2022
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information