APPLICATION
NDA017851
TYPE
NDA
ORIGINAL APPROVAL
1977-11-22
LATEST ACTION
2000-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LIORESAL · ReferenceDiscontinued
BACLOFEN 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LIORESAL · ReferenceDiscontinued
BACLOFEN 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2000-04-11Manufacturing (CMC) · Supplement 41 · priorityAP
1999-04-21Manufacturing (CMC) · Supplement 40 · priorityAP
1995-08-18Manufacturing (CMC) · Supplement 38 · priorityAP
1995-08-18Manufacturing (CMC) · Supplement 39 · priorityAP
1990-04-05Manufacturing (CMC) · Supplement 36 · priorityAP
1989-11-17Labeling · Supplement 34AP
1989-04-07Manufacturing (CMC) · Supplement 31 · priorityAP
1986-02-28Labeling · Supplement 25AP
1985-05-14Manufacturing (CMC) · Supplement 29 · priorityAP
1985-01-24Manufacturing (CMC) · Supplement 17 · priorityAP
1984-11-16Manufacturing (CMC) · Supplement 28 · priorityAP
1984-03-21Labeling · Supplement 24AP
1984-02-28Manufacturing (CMC) · Supplement 27 · priorityAP
1984-02-15Manufacturing (CMC) · Supplement 26 · priorityAP
1983-03-07Manufacturing (CMC) · Supplement 23 · priorityAP
1983-03-02Labeling · Supplement 19AP
1982-10-18Manufacturing (CMC) · Supplement 22 · priorityAP
1982-03-18Manufacturing (CMC) · Supplement 21 · priorityAP
1982-01-20Labeling · Supplement 15AP
1981-09-24Manufacturing (CMC) · Supplement 16 · priorityAP
1981-05-14Manufacturing (CMC) · Supplement 13 · priorityAP
1981-05-14Manufacturing (CMC) · Supplement 14 · priorityAP
1981-04-21Manufacturing (CMC) · Supplement 12 · priorityAP
1981-02-03Manufacturing (CMC) · Supplement 7 · priorityAP
1980-10-06Manufacturing (CMC) · Supplement 11 · priorityAP
1980-05-23Manufacturing (CMC) · Supplement 9 · priorityAP
1980-03-19Labeling · Supplement 8AP
1979-12-31Manufacturing (CMC) · Supplement 5 · priorityAP
1979-12-31Manufacturing (CMC) · Supplement 4 · priorityAP
1979-04-13Manufacturing (CMC) · Supplement 6 · priorityAP
1979-03-21Manufacturing (CMC) · Supplement 3 · priorityAP
1978-05-16Manufacturing (CMC) · Supplement 2 · priorityAP
1978-04-04Labeling · Supplement 1AP
1977-11-22Type 1 - New Molecular Entity · Original · priorityAP
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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