APPLICATION
ANDA208928
TYPE
ANDA
ORIGINAL APPROVAL
2023-11-20
LATEST ACTION
2026-02-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
GABAPENTINDiscontinued
GABAPENTIN 400MG · CAPSULE · ORAL
GABAPENTINDiscontinued
GABAPENTIN 100MG · CAPSULE · ORAL
GABAPENTINDiscontinued
GABAPENTIN 300MG · CAPSULE · ORAL
Approval history
2026-02-18Labeling · Supplement 2 · standardAP
2024-10-15Labeling · Supplement 1 · standardAP
2023-11-20UNKNOWN · 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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