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Details for New Drug Application (NDA): 011665

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NDA 011665 describes MESTINON, which is a drug marketed by Valeant Pharms Llc, Valeant Pharm Intl, and Valeant Pharms, and is included in four NDAs. It is available from two suppliers. Additional details are available on the MESTINON profile page.

The generic ingredient in MESTINON is pyridostigmine bromide. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.

Summary for NDA: 011665

Tradename:
MESTINON
Applicant:
Valeant Pharms Llc
Ingredient:
pyridostigmine bromide
Patents:0
Therapeutic Class:Antimyasthenic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 011665

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 011665

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MESTINON
pyridostigmine bromide
TABLET, EXTENDED RELEASE;ORAL 011665 NDA Valeant Pharmaceuticals North America LLC 0187-3013 0187-3013-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-3013-30)
MESTINON
pyridostigmine bromide
TABLET, EXTENDED RELEASE;ORAL 011665 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-301 68682-301-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-301-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes


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