APPLICATION
ANDA217965
TYPE
ANDA
ORIGINAL APPROVAL
2024-04-08
LATEST ACTION
2026-01-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 800MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 600MG · TABLET · ORAL
Approval history
2026-01-14Labeling · Supplement 5 · standardAP
2024-12-31Labeling · Supplement 3 · standardAP
2024-07-08Labeling · Supplement 1 · standardAP
2024-04-08UNKNOWN · 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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