APPLICATION
ANDA206943
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-14
LATEST ACTION
2026-04-02
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
2026-04-02Labeling · Supplement 24 · standardAP
2024-12-19Labeling · Supplement 22 · standardAP
2024-12-19Labeling · Supplement 12 · standardAP
2024-12-19Labeling · Supplement 21 · standardAP
2020-09-16Labeling · Supplement 1 · standardAP
2020-09-16Labeling · Supplement 4 · standardAP
2018-05-14UNKNOWN · Original · 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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