APPLICATION
ANDA206402
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-23
LATEST ACTION
2026-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 800MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 600MG · TABLET · ORAL
Approval history
2026-04-02Labeling · Supplement 27 · standardAP
2024-12-17Labeling · Supplement 26 · standardAP
2022-03-31Labeling · Supplement 20 · standardAP
2021-04-29Labeling · Supplement 14 · standardAP
2021-04-29Labeling · Supplement 5 · standardAP
2021-04-29Labeling · Supplement 3 · standardAP
2021-04-29Labeling · Supplement 17 · standardAP
2017-01-09Manufacturing (CMC) · Supplement 1 · unknownAP
2015-12-23UNKNOWN · 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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