Details for New Drug Application (NDA): 212512
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NDA 212512 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 212512
| Tradename: | NEOSTIGMINE METHYLSULFATE |
| Applicant: | Be Pharms |
| Ingredient: | neostigmine methylsulfate |
| Patents: | 0 |
Pharmacology for NDA: 212512
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 212512
Suppliers and Packaging for NDA: 212512
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 212512 | ANDA | Camber Pharmaceuticals Inc. | 31722-994 | 31722-994-31 | 10 VIAL, MULTI-DOSE in 1 CARTON (31722-994-31) / 10 mL in 1 VIAL, MULTI-DOSE |
| NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 212512 | ANDA | Camber Pharmaceuticals Inc. | 31722-995 | 31722-995-31 | 10 VIAL, MULTI-DOSE in 1 CARTON (31722-995-31) / 10 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5MG/10ML (0.5MG/ML) | ||||
| Approval Date: | May 13, 2019 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/10ML (1MG/ML) | ||||
| Approval Date: | May 13, 2019 | TE: | AP | RLD: | No | ||||
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