Details for New Drug Application (NDA): 212804
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NDA 212804 describes NEOSTIGMINE METHYLSULFATE, which is a drug marketed by Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Be Pharms, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Indoco, Meitheal, Nivagen Pharms Inc, Par Sterile Products, and Sagent Pharms Inc, and is included in eighteen NDAs. It is available from twenty-four 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 212804
| Tradename: | NEOSTIGMINE METHYLSULFATE |
| Applicant: | Meitheal |
| Ingredient: | neostigmine methylsulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
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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