This is an FDA approval record for a generic gabapentin formulation; it documents regulatory authorization but contains no clinical trial data or efficacy evidence.
Reported
Approval date2026-06-23
Formulation strengths300 mg, 600 mg
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Drug or technology
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This is an FDA approval record for a generic gabapentin formulation; it documents regulatory authorization but contains no clinical trial data or efficacy evidence.
MAY 14, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval for manufacturing changes to gabapentin formulations; does not report clinical efficacy or safety data.
MAY 1, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
This is an FDA supplemental approval action for gabapentin labeling; it documents a regulatory decision but does not report clinical trial data or efficacy outcomes.
APR 24, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval for labeling changes to gabapentin capsules; a regulatory action that does not report clinical trial outcomes or comparative efficacy data.
APR 2, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval for gabapentin labeling changes; describes a regulatory action, not clinical evidence of efficacy or safety.
APR 2, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval action for gabapentin labeling; documents regulatory decision but does not report clinical trial data or efficacy evidence.