← FDA DRUG APPROVALS

FDA NDA · NDA019910

RETROVIR

zidovudine

Sponsor: VIIV HLTHCARE

APPLICATION
NDA019910
TYPE
NDA
ORIGINAL APPROVAL
1989-09-28
LATEST ACTION
2024-12-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

RETROVIR · ReferencePrescription
ZIDOVUDINE 50MG/5ML · SOLUTION · ORAL

Approval history

2024-12-18Labeling · Supplement 48 · standard — Letter ↗AP
2020-06-18Labeling · Supplement 46 · standard — Letter ↗AP
2018-09-10Labeling · Supplement 45 · standard — Label ↗AP
2017-11-28Labeling · Supplement 44 · standard — Label ↗AP
2017-04-10Labeling · Supplement 43 · standard — Label ↗AP
2017-02-24Labeling · Supplement 42 · standard — Label ↗AP
2014-12-23Labeling · Supplement 41 · standard — Letter ↗AP
2012-05-31Labeling · Supplement 40 · standard — Letter ↗AP
2011-11-18Labeling · Supplement 39 · 901 required — Letter ↗AP
2010-05-17Labeling · Supplement 36 · standard — Label ↗AP
2009-11-06Efficacy · Supplement 35 · priority — Pediatric Medical Review ↗AP
2008-09-19Efficacy · Supplement 33 · priority — Pediatric Medical Review ↗AP
2006-11-15Labeling · Supplement 32 · standard — Label ↗AP
2006-05-10Labeling · Supplement 29 · standard — Label ↗AP
2003-10-15Labeling · Supplement 27 · standard — Label ↗AP
2002-12-18Labeling · Supplement 26 · standard — Letter ↗AP
2002-02-21Labeling · Supplement 25 · standard — Letter ↗AP
2001-10-05Labeling · Supplement 24 · standard — Label ↗AP
2001-03-30Labeling · Supplement 21 · standard — Letter ↗AP
2000-02-01Manufacturing (CMC) · Supplement 23AP
1999-02-26Manufacturing (CMC) · Supplement 22AP
1998-03-04Labeling · Supplement 19 · standardAP
1998-02-25Manufacturing (CMC) · Supplement 20AP
1996-10-04Efficacy · Supplement 18 · standardAP
1996-10-04Efficacy · Supplement 15 · unknownAP
1995-07-20Labeling · Supplement 16 · standardAP
1995-02-06Manufacturing (CMC) · Supplement 13AP
1994-10-07Labeling · Supplement 12 · standardAP
1994-08-08Efficacy · Supplement 11 · priorityAP
1994-08-08Labeling · Supplement 7AP
1993-08-24Labeling · Supplement 10 · standardAP
1992-10-19Manufacturing (CMC) · Supplement 8AP
1990-05-25Labeling · Supplement 1AP
1990-05-02Efficacy · Supplement 2AP
1990-03-02Efficacy · Supplement 4AP
1990-01-12Efficacy · Supplement 3AP
1989-09-28Type 3 - New Dosage Form · Original · priority — Pediatric Medical Review ↗AP
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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