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Product Details for NDA 214278

ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
EQ 20MG BASE
Marketing Status: Over-the-counter
Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Proprietary Name: ESOMEPRAZOLE MAGNESIUM
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214278
Product Number: 001
Approval Date: Oct 20, 2020
Applicant Holder Full Name: DEXCEL PHARMA TECHNOLOGIES LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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