Details for New Drug Application (NDA): 015193
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NDA 015193 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. Twenty-three 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. Twenty-three suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
Summary for 015193
| Tradename: | MESTINON |
| Applicant: | Bausch |
| Ingredient: | pyridostigmine bromide |
| Patents: | 0 |
Pharmacology for NDA: 015193
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 015193
Suppliers and Packaging for NDA: 015193
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MESTINON | pyridostigmine bromide | SYRUP;ORAL | 015193 | NDA | Bausch Health US, LLC | 0187-3012 | 0187-3012-20 | 473 mL in 1 BOTTLE (0187-3012-20) |
| MESTINON | pyridostigmine bromide | SYRUP;ORAL | 015193 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-307 | 68682-307-05 | 473 mL in 1 BOTTLE (68682-307-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 60MG/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | Yes | ||||
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