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Last Updated: October 25, 2021

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Details for New Drug Application (NDA): 211694

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NDA 211694 describes PYRIDOSTIGMINE BROMIDE, which is a drug marketed by Amneal, Elysium, Novitium Pharma, Alvogen, Impax Labs Inc, Rising, Ani Pharms, Eywa, Impax Labs, Solvay, Us Army, and Zydus Pharms, and is included in thirteen NDAs. It is available from thirteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
Summary for 211694
Applicant:Novitium Pharma
Ingredient:pyridostigmine bromide
Formulation / Manufacturing:see details
Pharmacology for NDA: 211694
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 211694
Suppliers and Packaging for NDA: 211694
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide SYRUP;ORAL 211694 ANDA VistaPharm, Inc. 66689-406 66689-406-10 1 TRAY in 1 CASE (66689-406-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (66689-406-01)
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide SYRUP;ORAL 211694 ANDA Novitium Pharma LLC 70954-148 70954-148-10 473 mL in 1 BOTTLE (70954-148-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength60MG/5ML
Approval Date:Mar 8, 2019TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

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