Details for New Drug Application (NDA): 017398
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The generic ingredient in REGONOL 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 017398
Tradename: | REGONOL |
Applicant: | Sandoz |
Ingredient: | pyridostigmine bromide |
Patents: | 0 |
Pharmacology for NDA: 017398
Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 017398
Suppliers and Packaging for NDA: 017398
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
REGONOL | pyridostigmine bromide | INJECTABLE;INJECTION | 017398 | NDA | Sandoz Inc | 0781-3040 | 0781-3040-95 | 10 AMPULE in 1 CARTON (0781-3040-95) / 2 mL in 1 AMPULE (0781-3040-72) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No |
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