Details for New Drug Application (NDA): 203629
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NDA 203629 describes NEOSTIGMINE METHYLSULFATE, which is a drug marketed by Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Avet Lifesciences, Be Pharms, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Meitheal, Ph Health, Regcon Holdings, Sagent Pharms Inc, and Umedica, and is included in nineteen NDAs. It is available from twenty-five suppliers. Additional details are available on the NEOSTIGMINE METHYLSULFATE profile page.
The generic ingredient in NEOSTIGMINE METHYLSULFATE is neostigmine methylsulfate. There are nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.
The generic ingredient in NEOSTIGMINE METHYLSULFATE is neostigmine methylsulfate. There are nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.
Summary for 203629
| Tradename: | NEOSTIGMINE METHYLSULFATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | neostigmine methylsulfate |
| Patents: | 0 |
Pharmacology for NDA: 203629
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 203629
Suppliers and Packaging for NDA: 203629
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 203629 | NDA | Fresenius Kabi USA, LLC | 63323-413 | 63323-413-36 | 10 VIAL, MULTI-DOSE in 1 TRAY (63323-413-36) / 10 mL in 1 VIAL, MULTI-DOSE |
| NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 203629 | NDA | Fresenius Kabi USA, LLC | 63323-413 | 63323-413-10 | 10 VIAL, MULTI-DOSE in 1 TRAY (63323-413-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-413-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5MG/10ML (0.5MG/ML) | ||||
| Approval Date: | Jan 8, 2015 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/10ML (1MG/ML) | ||||
| Approval Date: | Jan 8, 2015 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 3MG/3ML (1MG/ML) | ||||
| Approval Date: | Sep 18, 2018 | TE: | AP | RLD: | Yes | ||||
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