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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022287

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DEXILANT (DEXLANSOPRAZOLE)
30MG
Marketing Status: Prescription
Active Ingredient: DEXLANSOPRAZOLE
Proprietary Name: DEXILANT
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022287
Product Number: 001
Approval Date: Jan 30, 2009
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DEXILANT (DEXLANSOPRAZOLE)
60MG
Marketing Status: Prescription
Active Ingredient: DEXLANSOPRAZOLE
Proprietary Name: DEXILANT
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022287
Product Number: 002
Approval Date: Jan 30, 2009
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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