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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078279

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ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
EQ 20MG BASE
Marketing Status: Prescription
Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Proprietary Name: ESOMEPRAZOLE MAGNESIUM
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078279
Product Number: 001
Approval Date: Sep 25, 2015
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
EQ 40MG BASE
Marketing Status: Prescription
Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Proprietary Name: ESOMEPRAZOLE MAGNESIUM
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078279
Product Number: 002
Approval Date: Sep 25, 2015
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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