APPLICATION
ANDA091606
TYPE
ANDA
ORIGINAL APPROVAL
2011-12-02
LATEST ACTION
2019-10-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LAMIVUDINEPrescription
LAMIVUDINE 150MG · TABLET · ORAL
LAMIVUDINEPrescription
LAMIVUDINE 300MG · TABLET · ORAL
Approval history
2019-10-03Labeling · Supplement 9 · standardAP
2019-10-03Labeling · Supplement 7 · standardAP
2019-10-03Labeling · Supplement 10 · standardAP
2019-10-03Labeling · Supplement 8 · standardAP
2015-12-31Labeling · Supplement 4 · standardAP
2015-12-31Labeling · Supplement 5 · standardAP
2015-12-31Labeling · Supplement 3 · standardAP
2015-12-31Labeling · Supplement 1 · standardAP
2015-12-31Labeling · Supplement 6 · standardAP
2011-12-02OriginalAP
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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