APPLICATION
ANDA077268
TYPE
ANDA
ORIGINAL APPROVAL
2005-09-19
LATEST ACTION
2020-12-09
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ZIDOVUDINEPrescription
ZIDOVUDINE 50MG/5ML · SOLUTION · ORAL
Approval history
2020-12-09Labeling · Supplement 19 · standardAP
2020-06-11Labeling · Supplement 16 · standardAP
2020-06-11Labeling · Supplement 14 · standardAP
2020-06-11Labeling · Supplement 15 · standardAP
2020-06-11Labeling · Supplement 18 · standardAP
2015-12-11Manufacturing (CMC) · Supplement 12 · unknownAP
2012-10-30Labeling · Supplement 8 · standardAP
2012-03-06Labeling · Supplement 7AP
2011-12-30Labeling · Supplement 6AP
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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