Details for New Drug Application (NDA): 011665
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NDA 011665 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 011665
| Tradename: | MESTINON |
| Applicant: | Bausch |
| Ingredient: | pyridostigmine bromide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 011665
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 011665
Suppliers and Packaging for NDA: 011665
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MESTINON | pyridostigmine bromide | TABLET, EXTENDED RELEASE;ORAL | 011665 | NDA | Bausch Health US, LLC | 0187-3013 | 0187-3013-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-3013-30) |
| MESTINON | pyridostigmine bromide | TABLET, EXTENDED RELEASE;ORAL | 011665 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-301 | 68682-301-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-301-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 180MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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