Last Updated: September 24, 2026

Details for New Drug Application (NDA): 204737

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NDA 204737 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-one suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.

Summary for 204737

Tradename:	PYRIDOSTIGMINE BROMIDE
Applicant:	Alvogen
Ingredient:	pyridostigmine bromide
Patents:	0

Pharmacology for NDA: 204737

Mechanism of Action	Cholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for 204737

Cholinesterase Inhibitors

Suppliers and Packaging for NDA: 204737

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	TABLET, EXTENDED RELEASE;ORAL	204737	ANDA	Alvogen, Inc.	47781-335	47781-335-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-335-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	180MG
Approval Date:	Jun 26, 2015	TE:	AB	RLD:	No

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