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Last Updated: December 22, 2024

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. 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. Additional details are available on the chlorpheniramine maleate; hydrocodone bitartrate profile page.

Summary for 206891

Tradename:	HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE
Applicant:	Acella
Ingredient:	chlorpheniramine maleate; hydrocodone bitartrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	4MG/5ML;5MG/5ML
Approval Date:	Jun 9, 2017	TE:		RLD:	No

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