Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215331

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BORTEZOMIB (BORTEZOMIB)
3.5MG/1.4ML (2.5MG/ML)
Marketing Status: Discontinued

Active Ingredient: BORTEZOMIB
Proprietary Name: BORTEZOMIB
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 3.5MG/1.4ML (2.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215331
Product Number: 002
Approval Date: Jul 27, 2022
Applicant Holder Full Name: MAIA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

BORTEZOMIB (BORTEZOMIB)
3.5MG/3.5ML (1MG/ML)
Marketing Status: Discontinued

Active Ingredient: BORTEZOMIB
Proprietary Name: BORTEZOMIB
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 3.5MG/3.5ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215331
Product Number: 001
Approval Date: Jul 27, 2022
Applicant Holder Full Name: MAIA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information