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Last Updated: September 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205464

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NDA 205464 describes PYRIDOSTIGMINE BROMIDE, which is a drug marketed by Amneal, Invatech, Novitium Pharma, Alvogen, Impax Labs Inc, Rising, Ani Pharms Inc, Elysium, Impax Labs, Solvay, Us Army, and Zydus Pharms, and is included in thirteen NDAs. It is available from fourteen suppliers. Additional details are available on the PYRIDOSTIGMINE BROMIDE profile page.

The generic ingredient in PYRIDOSTIGMINE BROMIDE is pyridostigmine bromide. There are eleven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
Summary for 205464
Tradename:PYRIDOSTIGMINE BROMIDE
Applicant:Rising
Ingredient:pyridostigmine bromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205464
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 205464
Suppliers and Packaging for NDA: 205464
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 205464 ANDA Rising Pharmaceuticals, Inc. 64980-220 64980-220-03 30 TABLET in 1 BOTTLE (64980-220-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Aug 15, 2017TE:ABRLD:No

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