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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202342

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ESOMEPRAZOLE STRONTIUM (ESOMEPRAZOLE STRONTIUM)
24.65MG
Marketing Status: Discontinued
Active Ingredient: ESOMEPRAZOLE STRONTIUM
Proprietary Name: ESOMEPRAZOLE STRONTIUM
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 24.65MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202342
Product Number: 001
Approval Date: Aug 6, 2013
Applicant Holder Full Name: BELCHER PHARMATECH LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ESOMEPRAZOLE STRONTIUM (ESOMEPRAZOLE STRONTIUM)
49.3MG
Marketing Status: Discontinued
Active Ingredient: ESOMEPRAZOLE STRONTIUM
Proprietary Name: ESOMEPRAZOLE STRONTIUM
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 49.3MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202342
Product Number: 002
Approval Date: Aug 6, 2013
Applicant Holder Full Name: BELCHER PHARMATECH LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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