APPLICATION
ANDA078504
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-18
LATEST ACTION
2015-04-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BACLOFENPrescription
BACLOFEN 10MG · TABLET · ORAL
Approval history
2015-04-15Labeling · Supplement 5 · standardAP
2015-04-15Labeling · Supplement 4AP
2011-12-28Labeling · Supplement 2AP
2010-03-25Labeling · Supplement 1AP
2009-09-18OriginalAP
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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