Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204078

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BLOXIVERZ (NEOSTIGMINE METHYLSULFATE)
5MG/10ML (0.5MG/ML)
Marketing Status: Prescription

Active Ingredient: NEOSTIGMINE METHYLSULFATE
Proprietary Name: BLOXIVERZ
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 5MG/10ML (0.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N204078
Product Number: 001
Approval Date: May 31, 2013
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BLOXIVERZ (NEOSTIGMINE METHYLSULFATE)
5MG/5ML (1MG/ML)
Marketing Status: Prescription

Active Ingredient: NEOSTIGMINE METHYLSULFATE
Proprietary Name: BLOXIVERZ
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 5MG/5ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204078
Product Number: 003
Approval Date: Oct 27, 2023
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BLOXIVERZ (NEOSTIGMINE METHYLSULFATE)
10MG/10ML (1MG/ML)
Marketing Status: Prescription

Active Ingredient: NEOSTIGMINE METHYLSULFATE
Proprietary Name: BLOXIVERZ
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/10ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N204078
Product Number: 002
Approval Date: May 31, 2013
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information