Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207920

NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM)
EQ 20MG BASE
Marketing Status: Over-the-counter
Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Proprietary Name: NEXIUM 24HR
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207920
Product Number: 001
Approval Date: Nov 23, 2015
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Over-the-counter
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