APPLICATION
ANDA217546
TYPE
ANDA
ORIGINAL APPROVAL
2023-05-12
LATEST ACTION
2026-01-14
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
2026-01-14Labeling · Supplement 7 · standardAP
2024-12-31Labeling · Supplement 6 · standardAP
2023-07-17Labeling · Supplement 1 · standardAP
2023-05-12UNKNOWN · 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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