← FDA DRUG APPROVALS

FDA NDA · NDA020075

LIORESAL (BACLOFEN)

baclofen

Sponsor: AMNEAL

APPLICATION
NDA020075
TYPE
NDA
ORIGINAL APPROVAL
1992-06-17
LATEST ACTION
2021-12-13
ROUTE
INTRATHECAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LIORESAL · ReferencePrescription
BACLOFEN 0.05MG/ML · INJECTABLE · INTRATHECAL
LIORESAL · ReferencePrescription
BACLOFEN 0.5MG/ML · INJECTABLE · INTRATHECAL
LIORESAL · ReferencePrescription
BACLOFEN 2MG/ML · INJECTABLE · INTRATHECAL

Approval history

2021-12-13Manufacturing (CMC) · Supplement 38 — Letter ↗AP
2019-01-16Labeling · Supplement 37 · standard — Label ↗AP
2016-12-22Manufacturing (CMC) · Supplement 33 · standardAP
2016-09-30Labeling · Supplement 32 · standard — Letter ↗AP
2016-06-07Manufacturing (CMC) · Supplement 29 · priorityAP
2014-11-19Labeling · Supplement 31 · standard — Letter ↗AP
2014-06-05Manufacturing (CMC) · Supplement 30 · priorityAP
2013-11-19Labeling · Supplement 28 · standard — Letter ↗AP
2013-09-05Manufacturing (CMC) · Supplement 27 · priorityAP
2013-03-06Manufacturing (CMC) · Supplement 26 · priority — Label ↗AP
2013-01-10Manufacturing (CMC) · Supplement 25 · priorityAP
2011-11-13Labeling · Supplement 24 · unknown — Label ↗AP
2011-03-25Labeling · Supplement 21 · standard — Letter ↗AP
2003-05-08Manufacturing (CMC) · Supplement 20 · priority — Letter ↗AP
2003-01-17Manufacturing (CMC) · Supplement 19 · priority — Letter ↗AP
2002-12-10Manufacturing (CMC) · Supplement 18 · priorityAP
2002-11-21Manufacturing (CMC) · Supplement 17 · priority — Letter ↗AP
2002-03-06Labeling · Supplement 16 · standard — Letter ↗AP
2002-03-06Labeling · Supplement 14 · standard — Letter ↗AP
2001-05-03Manufacturing (CMC) · Supplement 15 · priorityAP
2000-03-03Manufacturing (CMC) · Supplement 6 · priorityAP
1999-05-05Manufacturing (CMC) · Supplement 12 · priorityAP
1998-08-21Manufacturing (CMC) · Supplement 9 · priorityAP
1998-08-21Manufacturing (CMC) · Supplement 8 · priorityAP
1998-06-23Manufacturing (CMC) · Supplement 7 · priorityAP
1996-11-07Manufacturing (CMC) · Supplement 5 · priorityAP
1996-06-14Efficacy · Supplement 4 · standardAP
1994-05-20Manufacturing (CMC) · Supplement 2 · priorityAP
1992-06-17Type 3 - New Dosage Form · Original · priorityAP
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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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