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LEVOCETIRIZINE DIHYDROCHLORIDE
Sponsor: MICRO LABS LTD INDIA
APPLICATION
ANDA202046
TYPE
ANDA
ORIGINAL APPROVAL
2013-09-17
LATEST ACTION
2026-01-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVOCETIRIZINE DIHYDROCHLORIDEPrescription
LEVOCETIRIZINE DIHYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-01-07Labeling · Supplement 18 · standardAP
2025-07-11Labeling · Supplement 17 · standardAP
2025-06-13Labeling · Supplement 12 · standardAP
2025-06-13Labeling · Supplement 9 · standardAP
2025-06-13Labeling · Supplement 13 · standardAP
2017-08-31Manufacturing (CMC) · Supplement 7AP
2017-08-31Labeling · Supplement 5 · standardAP
2017-08-31Labeling · Supplement 8 · standardAP
2017-08-31Labeling · Supplement 6 · standardAP
2015-10-01Labeling · Supplement 2 · standardAP
2015-10-01Labeling · Supplement 1 · standardAP
2013-09-17Not Applicable · OriginalAP
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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