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Last Updated: March 9, 2021

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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. There are five 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. Additional details are available on the aspirin profile page.
Summary for 203697
Tradename:VAZALORE
Applicant:Plx Pharma
Ingredient:aspirin
Patents:5
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 203697
Generic Entry Date for 203697*:
Constraining patent/regulatory exclusivity:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength325MG
Approval Date:Jan 14, 2013TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 23, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 23, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TEMPORARY REDUCTION OF FEVER
Patent:  Start TrialPatent Expiration:Mar 23, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TEMPORARY RELIEF OF MINOR ACHES AND PAINS

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