APPLICATION
ANDA211313
TYPE
ANDA
ORIGINAL APPROVAL
2024-03-04
LATEST ACTION
2025-09-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 400MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 800MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 100MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 600MG · TABLET · ORAL
Approval history
2025-09-05Labeling · Supplement 4 · standardAP
2025-09-05Labeling · Supplement 2 · standardAP
2024-03-04UNKNOWN · 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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