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Last Updated: September 25, 2020

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Details for New Drug Application (NDA): 205650

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NDA 205650 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 205650
Applicant:Zydus Pharms
Ingredient:pyridostigmine bromide
Formulation / Manufacturing:see details
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 Cadila Healthcare Limited 65841-819 65841-819-01 100 TABLET in 1 BOTTLE (65841-819-01)

Profile for product number 001

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

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