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 17, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206891

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NDA 206891 describes HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE, which is a drug marketed by Acella and Tris Pharma Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE profile page.

The generic ingredient in HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE is chlorpheniramine maleate; hydrocodone bitartrate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine maleate; hydrocodone bitartrate profile page.
Pharmacology for NDA: 206891
Suppliers and Packaging for NDA: 206891
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE chlorpheniramine maleate; hydrocodone bitartrate SOLUTION;ORAL 206891 ANDA Acella Pharmaceuticals, LLC 42192-612 42192-612-16 480 mL in 1 BOTTLE (42192-612-16)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength4MG/5ML;5MG/5ML
Approval Date:Jun 9, 2017TE:RLD:No

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