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FDA NDA · NDA019951

RETROVIR

zidovudine

Sponsor: VIIV HLTHCARE

APPLICATION
NDA019951
TYPE
NDA
ORIGINAL APPROVAL
1990-02-02
LATEST ACTION
2024-11-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

RETROVIR · ReferencePrescription
ZIDOVUDINE 10MG/ML · INJECTABLE · INJECTION

Approval history

2024-11-11Manufacturing (CMC) · Supplement 38AP
2024-11-11Manufacturing (CMC) · Supplement 39 — Label ↗AP
2020-06-18Labeling · Supplement 37 · standard — Letter ↗AP
2018-09-10Labeling · Supplement 36 · standard — Label ↗AP
2017-11-28Labeling · Supplement 35 · standard — Label ↗AP
2017-04-10Labeling · Supplement 34 · standard — Label ↗AP
2017-02-24Labeling · Supplement 33 · standard — Label ↗AP
2014-12-23Labeling · Supplement 32 · standard — Label ↗AP
2013-12-19Manufacturing (CMC) · Supplement 31AP
2012-05-31Labeling · Supplement 30 · standard — Letter ↗AP
2011-11-18Labeling · Supplement 29 · 901 required — Letter ↗AP
2006-11-15Labeling · Supplement 24 · standard — Letter ↗AP
2006-07-10Labeling · Supplement 23 · standard — Letter ↗AP
2003-07-29Labeling · Supplement 19 · standard — Letter ↗AP
2003-07-25Labeling · Supplement 18 · standard — Label ↗AP
2002-08-19Manufacturing (CMC) · Supplement 20AP
2002-02-21Labeling · Supplement 17 · standard — Letter ↗AP
2001-09-12Labeling · Supplement 16 · standard — Label ↗AP
2000-02-01Manufacturing (CMC) · Supplement 15AP
1999-02-26Manufacturing (CMC) · Supplement 14AP
1998-03-04Labeling · Supplement 12 · standardAP
1998-02-12Labeling · Supplement 10 · standardAP
1997-08-18Manufacturing (CMC) · Supplement 11AP
1996-04-02Labeling · Supplement 9 · standardAP
1996-03-22Labeling · Supplement 8AP
1995-07-20Labeling · Supplement 7 · standardAP
1995-02-06Manufacturing (CMC) · Supplement 5AP
1994-10-07Labeling · Supplement 4 · standardAP
1994-08-08Efficacy · Supplement 3 · priorityAP
1992-08-07Manufacturing (CMC) · Supplement 1AP
1990-02-02Type 3 - New Dosage Form · Original · priorityAP
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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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