Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077781

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NDA 077781 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Aurobindo Pharma Ltd, Barr, Impax Labs, Mylan, Sun Pharm, Watson Labs, West-ward Pharms Int, 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 fifteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 077781
Tradename:GALANTAMINE HYDROBROMIDE
Applicant:Apotex Inc
Ingredient:galantamine hydrobromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077781
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 077781
Suppliers and Packaging for NDA: 077781
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077781 ANDA Apotex Corp. 60505-2542 60505-2542-0 10 BLISTER PACK in 1 CARTON (60505-2542-0) > 10 TABLET, FILM COATED in 1 BLISTER PACK
GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077781 ANDA Apotex Corp. 60505-2542 60505-2542-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-2542-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Sep 27, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Sep 27, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12MG BASE
Approval Date:Sep 27, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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Mallinckrodt
McKinsey
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