Details for New Drug Application (NDA): 011665
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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 011665
Tradename: | MESTINON |
Applicant: | Bausch |
Ingredient: | pyridostigmine bromide |
Patents: | 0 |
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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