Details for New Drug Application (NDA): 017398
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NDA 017398 describes REGONOL, which is a drug marketed by Sandoz Inc and is included in one NDA. It is available from one supplier. Additional details are available on the REGONOL profile page.
The generic ingredient in REGONOL 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 REGONOL 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 017398
| Tradename: | REGONOL |
| Applicant: | Sandoz Inc |
| Ingredient: | pyridostigmine bromide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
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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