Details for New Drug Application (NDA): 009829
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NDA 009829 describes MESTINON, which is a drug marketed by Bausch and is included in four NDAs. It is available from two suppliers. Additional details are available on the MESTINON profile page.
The generic ingredient in MESTINON is pyridostigmine bromide. There are eleven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
The generic ingredient in MESTINON is pyridostigmine bromide. There are eleven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
Summary for 009829
| Tradename: | MESTINON |
| Applicant: | Bausch |
| Ingredient: | pyridostigmine bromide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 009829
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 009829
Suppliers and Packaging for NDA: 009829
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MESTINON | pyridostigmine bromide | TABLET;ORAL | 009829 | NDA | Bausch Health US, LLC | 0187-3010 | 0187-3010-30 | 100 TABLET in 1 BOTTLE (0187-3010-30) |
| MESTINON | pyridostigmine bromide | TABLET;ORAL | 009829 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-302 | 68682-302-10 | 100 TABLET in 1 BOTTLE (68682-302-10) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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