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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 040502


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NDA 040502 describes PYRIDOSTIGMINE BROMIDE, which is a drug marketed by Amneal, Milla Pharms, MSN, Novitium Pharma, Rising, Alvogen, Impax Labs Inc, Ani Pharms, Impax Labs, MLV, Solvay, Us Army, and Zydus Pharms, and is included in fifteen NDAs. It is available from nineteen 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. Twenty-two suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
Summary for 040502
Tradename:PYRIDOSTIGMINE BROMIDE
Applicant:Impax Labs
Ingredient:pyridostigmine bromide
Patents:0
Pharmacology for NDA: 040502
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 040502
Suppliers and Packaging for NDA: 040502
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 040502 ANDA Amneal Pharmaceuticals of New York LLC 0115-2134 0115-2134-01 21 TABLET in 1 BOTTLE (0115-2134-01)
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 040502 ANDA Amneal Pharmaceuticals of New York LLC 0115-3511 0115-3511-01 100 TABLET in 1 BOTTLE (0115-3511-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Apr 24, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jun 28, 2022TE:ABRLD:No

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