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FDA ANDA · ANDA078730

LANSOPRAZOLE

Sponsor: ANI PHARMS

APPLICATION
ANDA078730
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-15
LATEST ACTION
2010-10-15
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

LANSOPRAZOLEDiscontinued
LANSOPRAZOLE 15MG · TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL
LANSOPRAZOLEDiscontinued
LANSOPRAZOLE 30MG · TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL

Approval history

2010-10-15OriginalReviewAP
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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