Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209933

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

Active Ingredient: NEOSTIGMINE METHYLSULFATE
Proprietary Name: NEOSTIGMINE METHYLSULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 5MG/10ML (0.5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A209933
Product Number: 001
Approval Date: Sep 25, 2017
Applicant Holder Full Name: AMPHASTAR PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: NEOSTIGMINE METHYLSULFATE
Proprietary Name: NEOSTIGMINE METHYLSULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/10ML (1MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A209933
Product Number: 002
Approval Date: Sep 25, 2017
Applicant Holder Full Name: AMPHASTAR PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information