APPLICATION
ANDA090561
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-27
LATEST ACTION
2025-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ZIDOVUDINEPrescription
ZIDOVUDINE 300MG · TABLET · ORAL
Approval history
2025-06-17Labeling · Supplement 14 · standardAP
2020-02-07Labeling · Supplement 13 · standardAP
2020-02-07Labeling · Supplement 8 · standardAP
2020-02-07Labeling · Supplement 12 · standardAP
2020-02-07Labeling · Supplement 10 · standardAP
2020-02-07Labeling · Supplement 7 · standardAP
2012-10-25Labeling · Supplement 5 · 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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