Details for New Drug Application (NDA): 206323

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NDA 206323 describes TUXARIN ER, which is a drug marketed by Mainpointe 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 TUXARIN ER profile page.

The generic ingredient in TUXARIN ER is chlorpheniramine maleate; codeine phosphate. 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; codeine phosphate profile page.

Summary for 206323

Tradename:	TUXARIN ER
Applicant:	Mainpointe
Ingredient:	chlorpheniramine maleate; codeine phosphate
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206323

Generic Entry Date for 206323^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 9,107,921 Dosage: TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 206323

Mechanism of Action	Full Opioid Agonists Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 206323

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323	NDA	Mainpointe Pharmaceuticals	71269-040	71269-040-10	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10)
TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323	NDA	Mainpointe Pharmaceuticals	71269-040	71269-040-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	8MG;54.3MG
Approval Date:	Jun 22, 2015	TE:		RLD:	No
Patent:	9,066,942	Patent Expiration:	Jan 3, 2032	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF COUGH AND SYMPTOMS ASSOCIATED WITH UPPER RESPIRATORY ALLERGIES OR A COMMON COLD WITH CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ORALLY ADMINISTERED EXTENDED RELEASE TABLETS
Patent:	9,107,921	Patent Expiration:	Jan 3, 2032	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 206323

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015	6,248,363	⤷ Subscribe
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015	6,383,471	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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