APPLICATION
ANDA075827
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-15
LATEST ACTION
2012-05-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GABAPENTINDiscontinued
GABAPENTIN 800MG · TABLET · ORAL
GABAPENTINDiscontinued
GABAPENTIN 600MG · TABLET · ORAL
Approval history
2012-05-21Labeling · Supplement 9 · standardAP
2012-04-16Labeling · Supplement 8AP
2006-04-10Labeling · Supplement 3AP
2005-05-20Labeling · Supplement 1AP
2004-12-15OriginalAP
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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