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FDA ANDA · ANDA090092

ZIDOVUDINE

Sponsor: HETERO LABS LTD III

APPLICATION
ANDA090092
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-25
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 8 · standardAP
2020-02-10Labeling · Supplement 6 · standardAP
2020-02-10Labeling · Supplement 9 · standardAP
2010-02-25Labeling · Supplement 2AP
2009-03-05Labeling · Supplement 1AP
2008-04-25OriginalLetterAP
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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