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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211751

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ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
EQ 20MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Proprietary Name: ESOMEPRAZOLE MAGNESIUM
Dosage Form; Route of Administration: FOR SUSPENSION, DELAYED RELEASE; ORAL
Strength: EQ 20MG BASE/PACKET
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211751
Product Number: 001
Approval Date: Mar 23, 2020
Applicant Holder Full Name: CIPLA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
EQ 40MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Proprietary Name: ESOMEPRAZOLE MAGNESIUM
Dosage Form; Route of Administration: FOR SUSPENSION, DELAYED RELEASE; ORAL
Strength: EQ 40MG BASE/PACKET
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211751
Product Number: 002
Approval Date: Mar 23, 2020
Applicant Holder Full Name: CIPLA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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