➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Boehringer Ingelheim
Colorcon
McKinsey
Merck

Last Updated: October 25, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211694


Email this page to a colleague

« Back to Dashboard

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
Tradename:PYRIDOSTIGMINE BROMIDE
Applicant:Novitium Pharma
Ingredient:pyridostigmine bromide
Patents:0
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Merck
Medtronic
Dow
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.