APPLICATION
ANDA205101
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-04
LATEST ACTION
2026-02-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 600MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 800MG · TABLET · ORAL
Approval history
2026-02-17Labeling · Supplement 29 · standardAP
2024-12-31Labeling · Supplement 19 · standardAP
2024-12-31Labeling · Supplement 25 · standardAP
2024-12-31Labeling · Supplement 28 · standardAP
2020-09-29Labeling · Supplement 4 · standardAP
2020-09-29Labeling · Supplement 7 · standardAP
2020-09-29Labeling · Supplement 18 · standardAP
2020-09-29Labeling · Supplement 8 · standardAP
2020-09-29Labeling · Supplement 6 · standardAP
2017-12-27Manufacturing (CMC) · Supplement 5 · unknownAP
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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