APPLICATION
ANDA203934
TYPE
ANDA
ORIGINAL APPROVAL
2024-01-24
LATEST ACTION
2026-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 900MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 450MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 300MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 750MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 600MG · TABLET · ORAL
Approval history
2026-07-17Labeling · 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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