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FDA ANDA · ANDA076844

ZIDOVUDINE

Sponsor: HIKMA

APPLICATION
ANDA076844
TYPE
ANDA
ORIGINAL APPROVAL
2005-09-19
LATEST ACTION
2025-05-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ZIDOVUDINEDiscontinued
ZIDOVUDINE 300MG · TABLET · ORAL

Approval history

2025-05-23Labeling · Supplement 7 · standardAP
2012-10-31Labeling · Supplement 6 · standardAP
2011-04-12Labeling · Supplement 5AP
2009-04-08Labeling · Supplement 4AP
2007-05-24Labeling · Supplement 2AP
2007-04-04Labeling · Supplement 1AP
2005-09-19OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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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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