← FDA DRUG APPROVALS

FDA NDA · NDA022488

PREGABALIN

Sponsor: UPJOHN

APPLICATION
NDA022488
TYPE
NDA
ORIGINAL APPROVAL
2010-01-04
LATEST ACTION
2025-04-25
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

LYRICA · ReferencePrescription
PREGABALIN 20MG/ML · SOLUTION · ORAL

Approval history

2025-04-25Labeling · Supplement 22 · standard — Label ↗AP
2023-12-13Labeling · Supplement 18 · standard — Letter ↗AP
2020-04-03Labeling · Supplement 17 · standard — Letter ↗AP
2019-05-23Efficacy · Supplement 14 · priority — Label ↗AP
2018-05-03Efficacy · Supplement 13 · priority — Label ↗AP
2016-12-22Efficacy · Supplement 11 · standard — Label ↗AP
2016-03-09Labeling · Supplement 10 · standard — Label ↗AP
2013-12-23Manufacturing (CMC) · Supplement 8 — Label ↗AP
2013-02-28Efficacy · Supplement 7 · standard — Label ↗AP
2012-04-16Labeling · Supplement 6 · standard — Letter ↗AP
2011-08-24Labeling · Supplement 4 · unknown — Label ↗AP
2011-06-20Labeling · Supplement 5 · standard — Label ↗AP
2011-04-26Labeling · Supplement 3 · standard — Label ↗AP
2011-04-26Labeling · Supplement 1 · unknown — Label ↗AP
2011-04-26Labeling · Supplement 2 · standard — Letter ↗AP
2010-01-04Type 3 - New Dosage Form · 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →