APPLICATION
ANDA204989
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-18
LATEST ACTION
2026-02-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
RELGAABIPrescription
GABAPENTIN 300MG · CAPSULE · ORAL
RELGAABIPrescription
GABAPENTIN 400MG · CAPSULE · ORAL
RELGAABIPrescription
GABAPENTIN 100MG · CAPSULE · ORAL
RELGAABIPrescription
GABAPENTIN 200MG · CAPSULE · ORAL
Approval history
2026-02-17Labeling · Supplement 40 · standardAP
2024-12-31Labeling · Supplement 32 · standardAP
2024-12-31Labeling · Supplement 20 · standardAP
2024-12-31Labeling · Supplement 37 · standardAP
2020-09-29Labeling · Supplement 9 · standardAP
2020-09-29Labeling · Supplement 7 · standardAP
2020-09-29Labeling · Supplement 19 · standardAP
2020-09-29Labeling · Supplement 6 · standardAP
2020-09-29Labeling · Supplement 4 · standardAP
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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