APPLICATION
ANDA219115
TYPE
ANDA
ORIGINAL APPROVAL
2025-11-12
LATEST ACTION
2025-11-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
DEXLANSOPRAZOLEPrescription
DEXLANSOPRAZOLE 30MG · CAPSULE, DELAYED RELEASE · ORAL
DEXLANSOPRAZOLEPrescription
DEXLANSOPRAZOLE 60MG · CAPSULE, DELAYED RELEASE · ORAL
Approval history
2025-11-12UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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