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Last Updated: September 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211181

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NDA 211181 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 211181
Tradename:PYRIDOSTIGMINE BROMIDE
Applicant:Elysium
Ingredient:pyridostigmine bromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211181
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 211181
Suppliers and Packaging for NDA: 211181
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 211181 ANDA Method Pharmaceuticals, LLC 58657-810 58657-810-10 21 BLISTER PACK in 1 CARTON (58657-810-10) > 10 TABLET in 1 BLISTER PACK
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 211181 ANDA Method Pharmaceuticals, LLC 58657-810 58657-810-21 21 TABLET in 1 BOTTLE (58657-810-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Jul 20, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:May 14, 2019TE:RLD:No

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