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: December 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078648

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NDA 078648 describes DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE, which is a drug marketed by Avanthi Inc and is included in one NDA. It is available from one supplier. Additional details are available on the DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE profile page.

The generic ingredient in DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE is dexbrompheniramine maleate; pseudoephedrine sulfate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dexbrompheniramine maleate; pseudoephedrine sulfate profile page.
Suppliers and Packaging for NDA: 078648
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE dexbrompheniramine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 078648 ANDA KVK-TECH, INC. 10702-005 10702-005-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10702-005-03)
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE dexbrompheniramine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 078648 ANDA KVK-TECH, INC. 10702-005 10702-005-21 2 BLISTER PACK in 1 CARTON (10702-005-21) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength6MG;120MG
Approval Date:Feb 27, 2013TE:RLD:No

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