APPLICATION
ANDA076017
TYPE
ANDA
ORIGINAL APPROVAL
2004-04-28
LATEST ACTION
2015-07-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
GABAPENTINDiscontinued
GABAPENTIN 800MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 400MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 100MG · TABLET · ORAL
GABAPENTINDiscontinued
GABAPENTIN 600MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 300MG · TABLET · ORAL
Approval history
2015-07-20Labeling · Supplement 38 · standardAP
2015-07-20Labeling · Supplement 39 · standardAP
2014-09-25Labeling · Supplement 37 · standardAP
2012-07-19Labeling · Supplement 35 · standardAP
2012-04-16Labeling · Supplement 34AP
2011-09-29Labeling · Supplement 33AP
2011-08-25Labeling · Supplement 30AP
2009-11-18Labeling · Supplement 25AP
2008-07-14Labeling · Supplement 24AP
2008-04-28Labeling · Supplement 22AP
2008-01-17Labeling · Supplement 20AP
2005-12-20Labeling · Supplement 12AP
2005-04-29Labeling · Supplement 6AP
2005-04-29Supplement · Supplement 4AP
2005-04-29Supplement · Supplement 9AP
2005-04-29Supplement · Supplement 5AP
2004-09-20Labeling · Supplement 2AP
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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