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Last Updated: October 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078185

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NDA 078185 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Aurobindo Pharma Ltd, Barr, Impax Labs, Mylan, Sun Pharm, Watson Labs, Hikma, Apotex Inc, Dr Reddys Labs Ltd, Heritage Pharma, Sandoz, Yabao Pharm, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from twelve suppliers. Additional details are available on the GALANTAMINE HYDROBROMIDE profile page.

The generic ingredient in GALANTAMINE HYDROBROMIDE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 078185
Ingredient:galantamine hydrobromide
Formulation / Manufacturing:see details
Pharmacology for NDA: 078185
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 078185
Suppliers and Packaging for NDA: 078185
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALANTAMINE HYDROBROMIDE galantamine hydrobromide SOLUTION;ORAL 078185 ANDA West-Ward Pharmaceuticals Corp. 0054-0137 0054-0137-49 100 mL in 1 BOTTLE (0054-0137-49)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength4MG/ML
Approval Date:Jan 30, 2009TE:RLD:No

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