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FDA ANDA · ANDA202666

DEXLANSOPRAZOLE DELAYED RELEASE

dexlansoprazole

Sponsor: TWI PHARMS

APPLICATION
ANDA202666
TYPE
ANDA
ORIGINAL APPROVAL
2022-09-16
LATEST ACTION
2025-08-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

DEXLANSOPRAZOLEPrescription
DEXLANSOPRAZOLE 60MG · CAPSULE, DELAYED RELEASE · ORAL
DEXLANSOPRAZOLEPrescription
DEXLANSOPRAZOLE 30MG · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2025-08-14Labeling · Supplement 8 · standardAP
2025-08-14Labeling · Supplement 9 · standardAP
2022-09-16UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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