← FDA DRUG APPROVALS

FDA NDA · NDA020155

VIDEX

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA020155
TYPE
NDA
ORIGINAL APPROVAL
1991-10-09
LATEST ACTION
2006-11-29
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued

Products

VIDEXDiscontinued
DIDANOSINE 250MG/PACKET · FOR SOLUTION · ORAL
VIDEXDiscontinued
DIDANOSINE 100MG/PACKET · FOR SOLUTION · ORAL
VIDEXDiscontinued
DIDANOSINE 375MG/PACKET · FOR SOLUTION · ORAL
VIDEXDiscontinued
DIDANOSINE 167MG/PACKET · FOR SOLUTION · ORAL

Approval history

2006-11-29Labeling · Supplement 39 · standard — Letter ↗AP
2006-08-18Labeling · Supplement 38 · standard — Review ↗AP
2004-01-21Labeling · Supplement 34 · standard — Letter ↗AP
2003-03-04Labeling · Supplement 32 · standard — Label ↗AP
2002-09-25Labeling · Supplement 30 · standard — Review ↗AP
2002-09-25Labeling · Supplement 31 · standard — Review ↗AP
2002-04-01Efficacy · Supplement 28 · unknown — Label ↗AP
2001-11-16Labeling · Supplement 27 · standard — Label ↗AP
2001-09-10Labeling · Supplement 26 · standard — Label ↗AP
2001-07-27Labeling · Supplement 25 · standardAP
2000-07-24Efficacy · Supplement 24 · standard — Review ↗AP
2000-07-24Labeling · Supplement 23 · standard — Review ↗AP
2000-07-03Labeling · Supplement 22 · standardAP
1999-10-28Efficacy · Supplement 21 · priority — Review ↗AP
1999-07-01Efficacy · Supplement 20 · standard — Review ↗AP
1998-06-23Manufacturing (CMC) · Supplement 19AP
1998-04-23Labeling · Supplement 18 · standardAP
1996-07-17Efficacy · Supplement 16 · standard — Review ↗AP
1996-06-26Labeling · Supplement 12 · standardAP
1996-06-26Labeling · Supplement 17 · standardAP
1996-03-13Manufacturing (CMC) · Supplement 15AP
1995-08-21Labeling · Supplement 11 · standardAP
1995-08-21Labeling · Supplement 10 · standardAP
1995-08-21Labeling · Supplement 8 · standardAP
1995-08-21Labeling · Supplement 6 · standardAP
1995-07-14Manufacturing (CMC) · Supplement 14AP
1995-06-15Labeling · Supplement 13 · standardAP
1994-08-05Efficacy · Supplement 7 · priority — Review ↗AP
1994-02-10Labeling · Supplement 9 · standardAP
1994-02-10Labeling · Supplement 5 · standardAP
1992-09-25Efficacy · Supplement 4AP
1991-10-09Type 3 - New Dosage Form · Original · priority — Other Important Information from FDA ↗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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