APPLICATION
ANDA209855
TYPE
ANDA
ORIGINAL APPROVAL
2024-05-29
LATEST ACTION
2026-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GABAPENTINDiscontinued
GABAPENTIN 600MG · TABLET · ORAL
GABAPENTINDiscontinued
GABAPENTIN 800MG · TABLET · ORAL
Approval history
2026-02-24Labeling · Supplement 2 · standardAP
2024-10-11Labeling · Supplement 1 · standardAP
2024-05-29UNKNOWN · 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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