APPLICATION
ANDA078787
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-31
LATEST ACTION
2024-10-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 400MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 100MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 300MG · CAPSULE · ORAL
Approval history
2024-10-15Labeling · Supplement 41 · standardAP
2023-08-02Labeling · Supplement 34 · standardAP
2023-08-02Labeling · Supplement 32 · standardAP
2018-04-23Labeling · Supplement 22 · standardAP
2018-04-23Labeling · Supplement 20 · standardAP
2018-04-23Manufacturing (CMC) · Supplement 25 · unknownAP
2018-04-23Labeling · Supplement 17 · standardAP
2018-04-23Labeling · Supplement 16 · standardAP
2015-03-05Manufacturing (CMC) · Supplement 8 · unknownAP
2014-11-08Labeling · Supplement 14 · standardAP
2014-11-08Labeling · Supplement 10 · standardAP
2014-06-17Manufacturing (CMC) · Supplement 3AP
2011-12-15Labeling · Supplement 7AP
2011-08-30Labeling · Supplement 6AP
2011-01-10Labeling · Supplement 4AP
2009-11-18Labeling · Supplement 1AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.