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FDA NDA · NDA018662

ACCUTANE

Sponsor: HOFFMANN LA ROCHE

APPLICATION
NDA018662
TYPE
NDA
ORIGINAL APPROVAL
1982-05-07
LATEST ACTION
2010-10-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ACCUTANE · ReferenceDiscontinued
ISOTRETINOIN 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ACCUTANE · ReferenceDiscontinued
ISOTRETINOIN 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ACCUTANE · ReferenceDiscontinued
ISOTRETINOIN 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2010-10-22Labeling · Supplement 61 · priority — Letter ↗AP
2010-02-01Labeling · Supplement 60 · priority — Letter ↗AP
2008-11-19Labeling · Supplement 59 · priority — Letter ↗AP
2007-10-03Labeling · Supplement 58 · priority — Letter ↗AP
2006-01-13Supplement · Supplement 57 · priority — Review ↗AP
2005-08-12Labeling · Supplement 56 · priority — Review ↗AP
2005-08-10Supplement · Supplement 55 · priority — Review ↗AP
2004-08-24Labeling · Supplement 54 · priority — Review ↗AP
2004-03-26Manufacturing (CMC) · Supplement 53 · priority — Review ↗AP
2003-08-27Labeling · Supplement 48 · priority — Review ↗AP
2003-08-27Labeling · Supplement 52 · priority — Review ↗AP
2002-06-20Labeling · Supplement 51 · priority — Label ↗AP
2002-05-02Efficacy · Supplement 43 · priority — Letter ↗AP
2002-04-12Labeling · Supplement 47 · priority — Patient Package Insert ↗AP
2002-02-15Labeling · Supplement 46 · priority — Letter ↗AP
2001-12-31Labeling · Supplement 45 · priority — Letter ↗AP
2001-12-31Labeling · Supplement 41 · priority — Label ↗AP
2001-10-30Labeling · Supplement 44 · priority — Letter ↗AP
2001-01-11Manufacturing (CMC) · Supplement 42 · priority — Review ↗AP
2000-05-01Labeling · Supplement 39 · priority — Letter ↗AP
2000-05-01Labeling · Supplement 38 · priority — Review ↗AP
2000-05-01Labeling · Supplement 40 · priority — Letter ↗AP
1999-04-30Manufacturing (CMC) · Supplement 37 · priorityAP
1995-05-17Labeling · Supplement 34 · priorityAP
1994-01-13Labeling · Supplement 33 · priorityAP
1991-10-08Manufacturing (CMC) · Supplement 32 · priorityAP
1991-03-07Labeling · Supplement 30 · priorityAP
1990-10-16Manufacturing (CMC) · Supplement 31 · priorityAP
1990-04-16Labeling · Supplement 29 · priorityAP
1989-08-09Manufacturing (CMC) · Supplement 28 · priorityAP
1989-04-28Manufacturing (CMC) · Supplement 26 · priorityAP
1989-04-04Manufacturing (CMC) · Supplement 27 · priorityAP
1988-11-16Manufacturing (CMC) · Supplement 25 · priorityAP
1988-08-26Labeling · Supplement 24 · priorityAP
1988-01-07Manufacturing (CMC) · Supplement 23 · priorityAP
1987-10-19Labeling · Supplement 22 · priorityAP
1987-06-03Manufacturing (CMC) · Supplement 21 · priorityAP
1987-06-01Labeling · Supplement 20 · priorityAP
1987-02-26Manufacturing (CMC) · Supplement 19 · priorityAP
1986-06-06Labeling · Supplement 10 · priorityAP
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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