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Generated: May 24, 2017

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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 Impax Labs, Ani Pharms Inc, Us Army, Alvogen Malta, Zydus Pharms Usa Inc, Impax Labs Inc, and Solvay, and is included in eight NDAs. It is available from eight 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. Eleven suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.

Summary for NDA: 205650

Therapeutic Class:Antimyasthenic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 205650

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 205650

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
TABLET;ORAL 205650 ANDA Bryant Ranch Prepack 63629-5699 63629-5699-1 60 TABLET in 1 BOTTLE (63629-5699-1)

Summary for product number 001

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

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