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

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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200480

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NDA 200480 describes DYCLOPRO, which is a drug marketed by Novocol Inc and is included in one NDA. It is available from one supplier. Additional details are available on the DYCLOPRO profile page.

The generic ingredient in DYCLOPRO is dyclonine hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dyclonine hydrochloride profile page.
Summary for 200480
Tradename:DYCLOPRO
Applicant:Novocol Inc
Ingredient:dyclonine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200480
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DYCLOPRO dyclonine hydrochloride SOLUTION;TOPICAL 200480 ANDA Septodont Inc 0362-3918 0362-3918-10 1 BOTTLE in 1 CARTON (0362-3918-10) > 30 mL in 1 BOTTLE
DYCLOPRO dyclonine hydrochloride SOLUTION;TOPICAL 200480 ANDA Septodont Inc 0362-3971 0362-3971-05 1 BOTTLE in 1 BOTTLE (0362-3971-05) > 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.5%
Approval Date:Nov 20, 2018TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength1%
Approval Date:Nov 20, 2018TE:RLD:No

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