Details for New Drug Application (NDA): 212804
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The generic ingredient in NEOSTIGMINE METHYLSULFATE is neostigmine methylsulfate. There are nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.
Summary for 212804
Tradename: | NEOSTIGMINE METHYLSULFATE |
Applicant: | Meitheal |
Ingredient: | neostigmine methylsulfate |
Patents: | 0 |
Pharmacology for NDA: 212804
Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 212804
Suppliers and Packaging for NDA: 212804
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 212804 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-500 | 71288-500-11 | 10 VIAL, MULTI-DOSE in 1 CARTON (71288-500-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-500-10) |
NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 212804 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-501 | 71288-501-11 | 10 VIAL, MULTI-DOSE in 1 CARTON (71288-501-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-501-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5MG/10ML (0.5MG/ML) | ||||
Approval Date: | Apr 5, 2021 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/10ML (1MG/ML) | ||||
Approval Date: | Apr 5, 2021 | TE: | AP | RLD: | No |
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