APPLICATION
ANDA077558
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-05
LATEST ACTION
2019-08-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LAMIVUDINE AND ZIDOVUDINEPrescription
LAMIVUDINE 150MG, ZIDOVUDINE 300MG · TABLET · ORAL
Approval history
2019-08-27Labeling · Supplement 18 · standardAP
2019-08-27Labeling · Supplement 16 · standardAP
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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