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FDA ANDA · ANDA202319

BASIC CARE LANSOPRAZOLE

lansoprazole

Sponsor: PERRIGO R AND D

APPLICATION
ANDA202319
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-18
LATEST ACTION
2024-09-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Over-the-counter

Products

LANSOPRAZOLEOver-the-counter
LANSOPRAZOLE 15MG · CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2024-09-19Labeling · Supplement 29 · standardAP
2024-09-19Labeling · Supplement 33 · standardAP
2024-09-19Labeling · Supplement 34 · standardAP
2020-08-20Labeling · Supplement 15 · standardAP
2020-08-20Labeling · Supplement 20 · standardAP
2015-09-18Labeling · Supplement 12 · standardAP
2013-04-05Labeling · Supplement 6 · standardAP
2013-04-05Labeling · Supplement 5 · standardAP
2012-05-18OriginalLetterAP
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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