Details for New Drug Application (NDA): 211694

NDA 211694 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 211694

Tradename:	PYRIDOSTIGMINE BROMIDE
Applicant:	Novitium Pharma
Ingredient:	pyridostigmine bromide
Patents:	0

Pharmacology for NDA: 211694

Mechanism of Action

Cholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for 211694

Cholinesterase Inhibitors

Suppliers and Packaging for NDA: 211694

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	SYRUP;ORAL	211694	ANDA	VistaPharm, LLC	66689-406	66689-406-10	1 TRAY in 1 CASE (66689-406-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-406-01)
PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	SYRUP;ORAL	211694	ANDA	Novitium Pharma LLC	70954-148	70954-148-10	473 mL in 1 BOTTLE (70954-148-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	60MG/5ML
Approval Date:	Mar 8, 2019	TE:	AA	RLD:	No

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