APPLICATION
ANDA213226
TYPE
ANDA
ORIGINAL APPROVAL
2021-04-13
LATEST ACTION
2026-02-03
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PREGABALINPrescription
PREGABALIN 330MG · TABLET, EXTENDED RELEASE · ORAL
PREGABALINPrescription
PREGABALIN 82.5MG · TABLET, EXTENDED RELEASE · ORAL
PREGABALINPrescription
PREGABALIN 165MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-02-03Labeling · Supplement 5 · standardAP
2021-04-13UNKNOWN · 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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