Details for New Drug Application (NDA): 208230
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NDA 208230 describes NEOSTIGMINE METHYSULFATE, which is a drug marketed by Avet Lifesciences and is included in one NDA. It is available from one supplier. Additional details are available on the NEOSTIGMINE METHYSULFATE profile page.
The generic ingredient in NEOSTIGMINE METHYSULFATE 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.
The generic ingredient in NEOSTIGMINE METHYSULFATE 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 208230
| Tradename: | NEOSTIGMINE METHYSULFATE |
| Applicant: | Avet Lifesciences |
| Ingredient: | neostigmine methylsulfate |
| Patents: | 0 |
Pharmacology for NDA: 208230
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 208230
Suppliers and Packaging for NDA: 208230
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEOSTIGMINE METHYSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 208230 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-517 | 23155-517-41 | 10 VIAL in 1 CARTON (23155-517-41) / 10 mL in 1 VIAL (23155-517-31) |
| NEOSTIGMINE METHYSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 208230 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-518 | 23155-518-41 | 10 VIAL in 1 CARTON (23155-518-41) / 10 mL in 1 VIAL (23155-518-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5MG/10ML (0.5MG/ML) | ||||
| Approval Date: | Nov 25, 2022 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/10ML (1MG/ML) | ||||
| Approval Date: | Nov 25, 2022 | TE: | AP | RLD: | No | ||||
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