Details for New Drug Application (NDA): 015193
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The generic ingredient in MESTINON is pyridostigmine bromide. There are eleven drug master file entries for this compound. Twenty-two 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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