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Generated: June 18, 2019

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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. Fifteen 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 ActionCholinesterase 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:RXDosage:INJECTABLE;INJECTIONStrength5MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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