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FDA NDA · NDA020154

VIDEX

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA020154
TYPE
NDA
ORIGINAL APPROVAL
1991-10-09
LATEST ACTION
2006-11-29
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

VIDEX · ReferenceDiscontinued
DIDANOSINE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL
VIDEX · ReferenceDiscontinued
DIDANOSINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL
VIDEX · ReferenceDiscontinued
DIDANOSINE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL
VIDEX · ReferenceDiscontinued
DIDANOSINE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL
VIDEX · ReferenceDiscontinued
DIDANOSINE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL

Approval history

2006-11-29Labeling · Supplement 50 · standard — Label ↗AP
2004-01-21Labeling · Supplement 44 · standard — Label ↗AP
2003-03-04Labeling · Supplement 42 · standard — Label ↗AP
2002-09-25Labeling · Supplement 41 · standard — Label ↗AP
2002-09-25Labeling · Supplement 40 · standard — Letter ↗AP
2002-08-23Manufacturing (CMC) · Supplement 39AP
2002-04-01Efficacy · Supplement 37 · unknown — Label ↗AP
2001-11-16Labeling · Supplement 36 · standard — Label ↗AP
2001-09-10Labeling · Supplement 35 · standard — Label ↗AP
2001-07-27Labeling · Supplement 34 · standardAP
2000-07-24Efficacy · Supplement 33 · standard — Review ↗AP
2000-07-24Labeling · Supplement 32 · standard — Review ↗AP
2000-07-03Labeling · Supplement 31 · standardAP
1999-10-28Efficacy · Supplement 29 · priority — Letter ↗AP
1999-10-28Manufacturing (CMC) · Supplement 30 — Review ↗AP
1999-07-01Efficacy · Supplement 28 · standard — Review ↗AP
1998-11-25Manufacturing (CMC) · Supplement 27AP
1998-11-25Manufacturing (CMC) · Supplement 26AP
1998-06-23Manufacturing (CMC) · Supplement 25AP
1998-04-23Labeling · Supplement 23 · standardAP
1998-01-05Manufacturing (CMC) · Supplement 24AP
1996-07-31Manufacturing (CMC) · Supplement 22AP
1996-07-17Efficacy · Supplement 20 · standard — Review ↗AP
1996-06-26Labeling · Supplement 21 · standardAP
1996-06-26Labeling · Supplement 16 · standardAP
1996-03-13Manufacturing (CMC) · Supplement 19AP
1996-02-27Manufacturing (CMC) · Supplement 11AP
1995-08-21Labeling · Supplement 14 · standardAP
1995-08-21Labeling · Supplement 12 · standardAP
1995-08-21Labeling · Supplement 15 · standardAP
1995-08-21Labeling · Supplement 8 · standardAP
1995-07-14Manufacturing (CMC) · Supplement 18AP
1995-06-15Labeling · Supplement 17 · standardAP
1994-08-05Efficacy · Supplement 9 · priority — Review ↗AP
1994-04-13Manufacturing (CMC) · Supplement 10AP
1994-02-10Labeling · Supplement 7 · standardAP
1994-02-10Labeling · Supplement 13 · standardAP
1993-02-04Manufacturing (CMC) · Supplement 4 — Review ↗AP
1992-09-25Efficacy · Supplement 6AP
1992-04-01Manufacturing (CMC) · Supplement 1AP
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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