APPLICATION
ANDA200651
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-06
LATEST ACTION
2024-09-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 800MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 600MG · TABLET · ORAL
Approval history
2024-09-26Labeling · Supplement 32 · standardAP
2021-10-15Labeling · Supplement 22 · standardAP
2020-10-19Labeling · Supplement 8 · standardAP
2020-10-19Labeling · Supplement 20 · standardAP
2020-10-19Labeling · Supplement 12 · standardAP
2020-10-19Labeling · Supplement 9 · standardAP
2020-10-19Labeling · Supplement 11 · standardAP
2015-03-31Manufacturing (CMC) · Supplement 5 · unknownAP
2015-02-18Labeling · Supplement 6 · standardAP
2014-10-23Labeling · Supplement 3 · standardAP
2011-10-06Not Applicable · OriginalAP
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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