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Last Updated: September 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203184

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NDA 203184 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 203184
Tradename:PYRIDOSTIGMINE BROMIDE
Applicant:Impax Labs Inc
Ingredient:pyridostigmine bromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203184
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 203184
Suppliers and Packaging for NDA: 203184
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 203184 ANDA Amneal Pharmaceuticals of New York LLC 0115-1404 0115-1404-08 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-1404-08)
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 203184 ANDA NuCare Pharmaceuticals,Inc. 68071-5032 68071-5032-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-5032-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Sep 15, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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