Details for New Drug Application (NDA): 203697

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NDA 203697 describes VAZALORE, which is a drug marketed by Plx Pharma and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the VAZALORE profile page.

The generic ingredient in VAZALORE is aspirin. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin profile page.

Summary for 203697

Tradename:	VAZALORE
Applicant:	Plx Pharma
Ingredient:	aspirin
Patents:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 203697

Generic Entry Date for 203697^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE;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: 203697

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Platelet Aggregation Decreased Prostaglandin Production

Medical Subject Heading (MeSH) Categories for 203697

Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Cyclooxygenase Inhibitors
Fibrinolytic Agents
Platelet Aggregation Inhibitors

Suppliers and Packaging for NDA: 203697

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VAZALORE	aspirin	CAPSULE;ORAL	203697	NDA	PLx Pharma Inc	73089-081	73089-081-12	1 BLISTER PACK in 1 CARTON (73089-081-12) / 81 mg in 1 BLISTER PACK
VAZALORE	aspirin	CAPSULE;ORAL	203697	NDA	PLx Pharma Inc	73089-081	73089-081-14	81 mg in 1 CARTON (73089-081-14)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	325MG
Approval Date:	Jan 14, 2013	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 29, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Sep 29, 2032	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A METHOD OF TARGETING RELEASE OF A NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) TO THE SMALL INTESTINE OF THE SUBJECT WHEN ADMINISTERED ORALLY
Patent:	⤷ Sign Up	Patent Expiration:	Sep 29, 2032	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 203697

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013	⤷ Sign Up	⤷ Sign Up
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013	⤷ Sign Up	⤷ Sign Up
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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