APPLICATION
ANDA078957
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-29
LATEST ACTION
2015-06-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
STAVUDINEDiscontinued
STAVUDINE 20MG · CAPSULE · ORAL
STAVUDINEDiscontinued
STAVUDINE 30MG · CAPSULE · ORAL
STAVUDINEDiscontinued
STAVUDINE 15MG · CAPSULE · ORAL
STAVUDINEDiscontinued
STAVUDINE 40MG · CAPSULE · ORAL
Approval history
2015-06-24Manufacturing (CMC) · Supplement 5 · unknownAP
2009-09-02Labeling · Supplement 2AP
2009-05-27Labeling · Supplement 1AP
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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