APPLICATION
ANDA078349
TYPE
ANDA
ORIGINAL APPROVAL
2007-05-23
LATEST ACTION
2025-04-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ZIDOVUDINEPrescription
ZIDOVUDINE 100MG · CAPSULE · ORAL
Approval history
2025-04-25Labeling · Supplement 24 · standardAP
2019-01-04Labeling · Supplement 23 · standardAP
2019-01-04Labeling · Supplement 22 · standardAP
2017-06-28Labeling · Supplement 21 · standardAP
2017-06-28Labeling · Supplement 20 · standardAP
2015-11-19Labeling · Supplement 18 · standardAP
2012-08-08Labeling · Supplement 14 · standardAP
2012-01-20Labeling · Supplement 12AP
2011-10-31Labeling · Supplement 11AP
2011-05-04Labeling · Supplement 8AP
2009-03-27Labeling · Supplement 5AP
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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