APPLICATION
ANDA078428
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-25
LATEST ACTION
2024-12-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 100MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 300MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 400MG · CAPSULE · ORAL
Approval history
2024-12-10Labeling · Supplement 59 · standardAP
2023-08-02Labeling · Supplement 47 · standardAP
2023-08-02Labeling · Supplement 53 · standardAP
2020-08-21Labeling · Supplement 43 · standardAP
2020-08-21Labeling · Supplement 33 · standardAP
2020-08-21Labeling · Supplement 36 · standardAP
2016-11-08Labeling · Supplement 29 · standardAP
2016-11-08Labeling · Supplement 27 · standardAP
2016-11-08Labeling · Supplement 25 · standardAP
2016-11-08Labeling · Supplement 31 · standardAP
2016-11-08Labeling · Supplement 28 · standardAP
2016-11-08Labeling · Supplement 26 · standardAP
2016-11-08Labeling · Supplement 24 · standardAP
2014-04-23Labeling · Supplement 22 · standardAP
2012-04-19Labeling · Supplement 17AP
2012-04-17Manufacturing (CMC) · Supplement 9AP
2011-12-16Manufacturing (CMC) · Supplement 14AP
2011-03-30Labeling · Supplement 15AP
2010-05-17Labeling · Supplement 4AP
2010-05-17Labeling · Supplement 7AP
2007-07-25OriginalAP
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.