← FDA DRUG APPROVALS

FDA NDA · NDA019655

RETROVIR

zidovudine

Sponsor: VIIV HLTHCARE

APPLICATION
NDA019655
TYPE
NDA
ORIGINAL APPROVAL
1987-03-19
LATEST ACTION
2024-12-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

RETROVIR · ReferencePrescription
ZIDOVUDINE 100MG · CAPSULE · ORAL

Approval history

2024-12-18Labeling · Supplement 60 · standard — Letter ↗AP
2020-06-18Labeling · Supplement 59 · standard — Letter ↗AP
2018-09-10Labeling · Supplement 58 · standard — Label ↗AP
2017-11-28Labeling · Supplement 57 · standard — Label ↗AP
2017-04-10Labeling · Supplement 56 · standard — Label ↗AP
2017-02-24Labeling · Supplement 55 · standard — Label ↗AP
2014-12-23Labeling · Supplement 54 · standard — Letter ↗AP
2012-05-31Labeling · Supplement 53 · standard — Letter ↗AP
2011-11-18Labeling · Supplement 52 · 901 required — Label ↗AP
2010-05-17Labeling · Supplement 49 · standard — Label ↗AP
2009-11-06Labeling · Supplement 48 · standard — Letter ↗AP
2008-09-19Efficacy · Supplement 46 · unknown — Label ↗AP
2006-11-15Labeling · Supplement 43 · standard — Letter ↗AP
2006-05-10Labeling · Supplement 41 · standard — Label ↗AP
2003-10-15Labeling · Supplement 39 · standard — Letter ↗AP
2002-12-18Labeling · Supplement 38 · standard — Letter ↗AP
2002-02-21Labeling · Supplement 37 · standard — Letter ↗AP
2001-10-05Labeling · Supplement 36 · standard — Label ↗AP
2001-03-30Labeling · Supplement 32 · standard — Review ↗AP
2000-02-01Manufacturing (CMC) · Supplement 35AP
1999-02-26Manufacturing (CMC) · Supplement 34AP
1998-12-28Manufacturing (CMC) · Supplement 33AP
1998-03-04Labeling · Supplement 30 · standardAP
1997-11-04Manufacturing (CMC) · Supplement 31AP
1996-10-04Efficacy · Supplement 26 · unknownAP
1996-10-04Efficacy · Supplement 29 · standardAP
1995-07-20Labeling · Supplement 27 · standardAP
1995-02-06Manufacturing (CMC) · Supplement 25AP
1994-10-07Labeling · Supplement 24 · standardAP
1994-08-08Labeling · Supplement 20AP
1994-08-08Efficacy · Supplement 23 · priorityAP
1993-08-24Labeling · Supplement 22 · standardAP
1993-08-24Labeling · Supplement 12AP
1993-08-24Labeling · Supplement 3AP
1990-05-02Labeling · Supplement 15AP
1990-04-30Manufacturing (CMC) · Supplement 14AP
1990-03-02Labeling · Supplement 11AP
1990-01-12Efficacy · Supplement 13AP
1989-03-13Manufacturing (CMC) · Supplement 9AP
1989-03-06Manufacturing (CMC) · Supplement 8AP
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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