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Last Updated: September 23, 2020

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Details for New Drug Application (NDA): 040502

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NDA 040502 describes PYRIDOSTIGMINE BROMIDE, which is a drug marketed by Amneal, Invatech, Novitium Pharma, Alvogen, Impax Labs Inc, Rising, Ani Pharms Inc, Elysium, Impax Labs, Solvay, Us Army, and Zydus Pharms, and is included in thirteen NDAs. It is available from fourteen 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. Eighteen 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
Formulation / Manufacturing:see details
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 0115-3511 0115-3511-01 100 TABLET in 1 BOTTLE (0115-3511-01)
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 040502 ANDA Amneal Pharmaceuticals of New York LLC 0115-3511 0115-3511-02 500 TABLET in 1 BOTTLE (0115-3511-02)

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

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