Details for New Drug Application (NDA): 203629
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NDA 203629 describes NEOSTIGMINE METHYLSULFATE, which is a drug marketed by Adaptis, Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Be Pharms, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Meitheal, Sagent Pharms Inc, and Umedica, and is included in eighteen NDAs. It is available from twenty-three 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-five 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-five 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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