FDA NDA · NDA020156

VIDEX

Sponsor: BRISTOL

APPLICATION

NDA020156

TYPE

NDA

ORIGINAL APPROVAL

1991-10-09

LATEST ACTION

2018-12-17

ROUTE

ORAL

DOSAGE FORM

FOR SOLUTION

MARKETING STATUS

Discontinued

Products

VIDEX · ReferenceDiscontinued

DIDANOSINE 10MG/ML · FOR SOLUTION · ORAL

Approval history

2018-12-17Labeling · Supplement 54 · standard — Label ↗AP

2018-01-25Labeling · Supplement 53 · standard — Label ↗AP

2014-08-08Labeling · Supplement 51 · standard — Label ↗AP

2011-11-18Labeling · Supplement 48 · 901 required — Letter ↗AP

2011-05-10REMS · Supplement 47 — Letter ↗AP

2010-01-25REMS · Supplement 46 · unknown — Label ↗AP

2009-06-11Labeling · Supplement 44 · standard — Label ↗AP

2006-11-29Labeling · Supplement 40 · standard — Label ↗AP

2006-08-18Labeling · Supplement 39 · standard — Review ↗AP

2004-01-21Labeling · Supplement 35 · standard — Label ↗AP

2003-03-04Labeling · Supplement 33 · standard — Letter ↗AP

2002-09-25Labeling · Supplement 31 · standard — Label ↗AP

2002-09-25Labeling · Supplement 32 · standard — Review ↗AP

2002-04-01Efficacy · Supplement 29 · unknown — Label ↗AP

2001-11-16Labeling · Supplement 28 · standard — Label ↗AP

2001-09-10Labeling · Supplement 27 · standard — Label ↗AP

2001-07-27Labeling · Supplement 26 · standardAP

2000-07-24Efficacy · Supplement 25 · standard — Review ↗AP

2000-07-24Labeling · Supplement 24 · standard — Review ↗AP

2000-07-03Labeling · Supplement 23 · standardAP

1999-10-28Efficacy · Supplement 22 · priority — Review ↗AP

1999-07-01Efficacy · Supplement 21 · standard — Review ↗AP

1998-06-23Manufacturing (CMC) · Supplement 19AP

1998-04-23Labeling · Supplement 18 · standardAP

1998-03-05Manufacturing (CMC) · Supplement 20AP

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 10 · standardAP

1995-08-21Labeling · Supplement 11 · 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 ↗

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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