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Last Updated: December 27, 2024

Details for New Drug Application (NDA): 205650


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NDA 205650 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 sixteen NDAs. It is available from twenty suppliers. There are eight patents protecting this drug. 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-three suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
Summary for 205650
Tradename:PYRIDOSTIGMINE BROMIDE
Applicant:Zydus Pharms
Ingredient:pyridostigmine bromide
Patents:0
Pharmacology for NDA: 205650
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 205650
Suppliers and Packaging for NDA: 205650
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 205650 ANDA Major Pharmaceuticals 0904-6622 0904-6622-61 100 BLISTER PACK in 1 CARTON (0904-6622-61) / 1 TABLET in 1 BLISTER PACK
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 205650 ANDA Golden State Medical Supply, Inc. 51407-590 51407-590-30 30 TABLET in 1 BOTTLE (51407-590-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Jun 22, 2015TE:ABRLD:No

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