Last Updated: November 8, 2026

Details for New Drug Application (NDA): 040457

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NDA 040457 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 sixteen NDAs. It is available from eighteen suppliers. There are nine patents protecting this drug. Additional details are available on the PYRIDOSTIGMINE BROMIDE profile page.

The generic ingredient in PYRIDOSTIGMINE BROMIDE is pyridostigmine bromide. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.

Summary for 040457

Tradename:	PYRIDOSTIGMINE BROMIDE
Applicant:	Impax Labs Inc
Ingredient:	pyridostigmine bromide
Patents:	0

Medical Subject Heading (MeSH) Categories for 040457

Cholinesterase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Dec 26, 2002	TE:		RLD:	No

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