APPLICATION
ANDA078128
TYPE
ANDA
ORIGINAL APPROVAL
2006-03-27
LATEST ACTION
2025-04-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ZIDOVUDINEPrescription
ZIDOVUDINE 100MG · CAPSULE · ORAL
Approval history
2025-04-21Labeling · Supplement 18 · standardAP
2025-04-21Labeling · Supplement 22 · standardAP
2020-04-08Labeling · Supplement 15 · standardAP
2020-04-08Labeling · Supplement 13 · standardAP
2020-04-08Labeling · Supplement 14 · standardAP
2020-04-08Labeling · Supplement 12 · standardAP
2015-06-26Labeling · Supplement 11 · standardAP
2012-08-01Labeling · Supplement 8AP
2012-08-01Labeling · Supplement 9 · standardAP
2010-11-04Labeling · Supplement 5AP
2010-06-14Labeling · Supplement 4AP
2009-05-13Labeling · Supplement 3AP
2008-06-09Labeling · Supplement 2AP
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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