APPLICATION
ANDA077267
TYPE
ANDA
ORIGINAL APPROVAL
2005-09-19
LATEST ACTION
2020-02-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ZIDOVUDINEPrescription
ZIDOVUDINE 300MG · TABLET · ORAL
Approval history
2020-02-10Labeling · Supplement 17 · standardAP
2020-02-10Labeling · Supplement 18 · standardAP
2020-02-10Labeling · Supplement 22 · standardAP
2020-02-10Labeling · Supplement 19 · standardAP
2015-06-26Labeling · Supplement 15 · standardAP
2012-10-30Labeling · Supplement 13 · standardAP
2012-02-28Labeling · Supplement 12AP
2011-05-19Manufacturing (CMC) · Supplement 10AP
2010-08-24Labeling · Supplement 11AP
2010-06-14Labeling · Supplement 9AP
2009-05-08Labeling · Supplement 8AP
2008-06-09Labeling · Supplement 6AP
2007-06-19Labeling · Supplement 3AP
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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