Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203697

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VAZALORE (ASPIRIN)
81MG
Marketing Status: Over-the-counter

Active Ingredient: ASPIRIN
Proprietary Name: VAZALORE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 81MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203697
Product Number: 002
Approval Date: Feb 26, 2021
Applicant Holder Full Name: PLX PHARMA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

VAZALORE (ASPIRIN)
325MG
Marketing Status: Over-the-counter

Active Ingredient: ASPIRIN
Proprietary Name: VAZALORE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 325MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203697
Product Number: 001
Approval Date: Jan 14, 2013
Applicant Holder Full Name: PLX PHARMA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information