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Last Updated: April 23, 2024

Details for New Drug Application (NDA): 040512

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NDA 040512 describes PYRIDOSTIGMINE BROMIDE, which is a drug marketed by Amneal, Milla Pharms, MSN, Novitium Pharma, Rising, Alvogen, Impax Labs Inc, Ani Pharms, Eywa, Impax Labs, 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 040512

Tradename:	PYRIDOSTIGMINE BROMIDE
Applicant:	Ani Pharms
Ingredient:	pyridostigmine bromide
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 040512

Mechanism of Action	Cholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for 040512

Cholinesterase Inhibitors

Suppliers and Packaging for NDA: 040512

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	TABLET;ORAL	040512	ANDA	ANI Pharmaceuticals, Inc.	62559-470	62559-470-01	100 TABLET in 1 BOTTLE (62559-470-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Oct 8, 2003	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Jul 20, 2005	TE:		RLD:	No

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