APPLICATION
ANDA077662
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-18
LATEST ACTION
2024-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 800MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 600MG · TABLET · ORAL
Approval history
2024-10-02Labeling · Supplement 36 · standardAP
2023-08-02Labeling · Supplement 29 · standardAP
2020-10-27Labeling · Supplement 23 · standardAP
2020-10-27Labeling · Supplement 26 · standardAP
2017-10-05Labeling · Supplement 21 · standardAP
2016-11-08Labeling · Supplement 19 · standardAP
2016-11-08Labeling · Supplement 17 · standardAP
2016-11-08Labeling · Supplement 15 · standardAP
2014-03-25Labeling · Supplement 13 · standardAP
2011-11-25Labeling · Supplement 10AP
2011-09-29Labeling · Supplement 9AP
2011-08-29Labeling · Supplement 8AP
2009-11-20Labeling · Supplement 6AP
2006-10-19Labeling · Supplement 1AP
2006-08-18OriginalAP
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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