← FDA DRUG APPROVALS

FDA NDA · NDA021446

LYRICA

pregabalin

Sponsor: UPJOHN

APPLICATION
NDA021446
TYPE
NDA
ORIGINAL APPROVAL
2004-12-30
LATEST ACTION
2025-04-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

LYRICA · ReferencePrescription
PREGABALIN 200MG · CAPSULE · ORAL
LYRICA · ReferencePrescription
PREGABALIN 100MG · CAPSULE · ORAL
LYRICA · ReferencePrescription
PREGABALIN 50MG · CAPSULE · ORAL
LYRICA · ReferencePrescription
PREGABALIN 225MG · CAPSULE · ORAL
LYRICA · ReferencePrescription
PREGABALIN 150MG · CAPSULE · ORAL
LYRICA · ReferencePrescription
PREGABALIN 75MG · CAPSULE · ORAL
LYRICA · ReferencePrescription
PREGABALIN 25MG · CAPSULE · ORAL
LYRICA · ReferencePrescription
PREGABALIN 300MG · CAPSULE · ORAL

Approval history

2025-04-25Labeling · Supplement 46 · standard — Label ↗AP
2023-12-13Labeling · Supplement 41 · standard — Letter ↗AP
2020-04-03Labeling · Supplement 40 · standard — Letter ↗AP
2019-05-23Efficacy · Supplement 36 · priority — Label ↗AP
2018-05-03Efficacy · Supplement 35 · priority — Label ↗AP
2016-12-22Efficacy · Supplement 32 · standard — Label ↗AP
2016-07-08Manufacturing (CMC) · Supplement 31 · priorityAP
2016-03-09Labeling · Supplement 30 · standard — Letter ↗AP
2013-12-23Labeling · Supplement 29 · standard — Label ↗AP
2012-06-20Efficacy · Supplement 28 · priority — Letter ↗AP
2011-08-24Labeling · Supplement 25 · unknown — Letter ↗AP
2011-06-20Labeling · Supplement 26 · standard — Letter ↗AP
2011-04-26Labeling · Supplement 23 · unknown — Label ↗AP
2011-04-26REMS · Supplement 24 — Label ↗AP
2010-10-08Labeling · Supplement 21 · unknown — Label ↗AP
2010-01-04Labeling · Supplement 18 · unknown — Letter ↗AP
2009-04-23Labeling · Supplement 13 · 901 required — Letter ↗AP
2009-04-23Labeling · Supplement 14 · standard — Letter ↗AP
2007-06-21Efficacy · Supplement 10 · priority — Label ↗AP
2006-10-27Labeling · Supplement 6 · standard — Letter ↗AP
2006-02-17Labeling · Supplement 2 · standard — Label ↗AP
2006-02-17Labeling · Supplement 3 · standard — Label ↗AP
2004-12-30Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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