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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 022556


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NDA 022556 describes KARBINAL ER, which is a drug marketed by Aytu and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the KARBINAL ER profile page.

The generic ingredient in KARBINAL ER is carbinoxamine maleate. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.
Summary for 022556
Tradename:KARBINAL ER
Applicant:Aytu
Ingredient:carbinoxamine maleate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022556
Suppliers and Packaging for NDA: 022556
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KARBINAL ER carbinoxamine maleate SUSPENSION, EXTENDED RELEASE;ORAL 022556 NDA Aytu Therapeutics, LLC 23594-101 23594-101-01 2 BOTTLE, PLASTIC in 1 CARTON (23594-101-01) > 30 mL in 1 BOTTLE, PLASTIC
KARBINAL ER carbinoxamine maleate SUSPENSION, EXTENDED RELEASE;ORAL 022556 NDA Aytu Therapeutics, LLC 23594-101 23594-101-05 480 mL in 1 BOTTLE, PLASTIC (23594-101-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;ORALStrength4MG/5ML
Approval Date:Mar 28, 2013TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 29, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 15, 2027Product Flag?YSubstance Flag?Delist Request?

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