← FDA DRUG APPROVALS

FDA NDA · NDA020632

MERIDIA

Sponsor: ABBOTT

APPLICATION
NDA020632
TYPE
NDA
ORIGINAL APPROVAL
1997-11-22
LATEST ACTION
2010-08-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

MERIDIADiscontinued
SIBUTRAMINE HYDROCHLORIDE 10MG · CAPSULE · ORAL
MERIDIADiscontinued
SIBUTRAMINE HYDROCHLORIDE 15MG · CAPSULE · ORAL
MERIDIADiscontinued
SIBUTRAMINE HYDROCHLORIDE 5MG · CAPSULE · ORAL

Approval history

2010-08-04Labeling · Supplement 35 · standard — Medication Guide ↗AP
2010-08-04Labeling · Supplement 34 · standard — Medication Guide ↗AP
2009-05-04Labeling · Supplement 32 · standard — Label ↗AP
2008-12-24Labeling · Supplement 31 · standard — Letter ↗AP
2008-05-29Labeling · Supplement 30 · standard — Letter ↗AP
2006-08-23Labeling · Supplement 26 · standard — Letter ↗AP
2005-12-08Efficacy · Supplement 21 · standard — Other Important Information from FDA ↗AP
2005-07-29Labeling · Supplement 24 · standard — Label ↗AP
2004-11-24Labeling · Supplement 20 · standard — Letter ↗AP
2004-11-24Manufacturing (CMC) · Supplement 19 · standard — Label ↗AP
2003-09-25Labeling · Supplement 17 · standard — Review ↗AP
2002-10-08Manufacturing (CMC) · Supplement 15 · standard — Review ↗AP
2002-08-07Manufacturing (CMC) · Supplement 14 · standard — Review ↗AP
2002-04-25Manufacturing (CMC) · Supplement 13 · standardAP
2001-02-16Efficacy · Supplement 8 · standard — Letter ↗AP
2001-02-16Efficacy · Supplement 11 · standard — Letter ↗AP
1999-11-12Labeling · Supplement 6 · standard — Review ↗AP
1999-07-06Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
1998-08-07Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1998-08-07Manufacturing (CMC) · Supplement 1 · standardAP
1997-11-22Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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