← FDA DRUG APPROVALS

FDA NDA · NDA209501

LYRICA CR

pregabalin

Sponsor: UPJOHN

APPLICATION
NDA209501
TYPE
NDA
ORIGINAL APPROVAL
2017-10-11
LATEST ACTION
2025-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

LYRICA CR · ReferencePrescription
PREGABALIN 330MG · TABLET, EXTENDED RELEASE · ORAL
LYRICA CR · ReferencePrescription
PREGABALIN 82.5MG · TABLET, EXTENDED RELEASE · ORAL
LYRICA CR · ReferencePrescription
PREGABALIN 165MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-04-25Labeling · Supplement 10 · standard — Label ↗AP
2023-12-13Labeling · Supplement 5 · standard — Letter ↗AP
2020-04-03Labeling · Supplement 3 · standard — Letter ↗AP
2017-10-11Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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