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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 216512


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NDA 216512 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 fifteen NDAs. It is available from nineteen 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. Twenty-two suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
Summary for 216512
Tradename:PYRIDOSTIGMINE BROMIDE
Applicant:Msn
Ingredient:pyridostigmine bromide
Patents:0
Pharmacology for NDA: 216512
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 216512
Suppliers and Packaging for NDA: 216512
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide SYRUP;ORAL 216512 ANDA Novadoz Pharmaceuticals LLC 72205-098 72205-098-72 473 mL in 1 BOTTLE (72205-098-72)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength60MG/5ML
Approval Date:Sep 21, 2023TE:AARLD:No

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