← FDA DRUG APPROVALS

FDA NDA · NDA021710

EQUETRO

carbamazepine

Sponsor: VALIDUS PHARMS

APPLICATION
NDA021710
TYPE
NDA
ORIGINAL APPROVAL
2004-12-10
LATEST ACTION
2022-10-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

EQUETRO · ReferencePrescription
CARBAMAZEPINE 300MG · CAPSULE, EXTENDED RELEASE · ORAL
EQUETRO · ReferencePrescription
CARBAMAZEPINE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
EQUETRO · ReferencePrescription
CARBAMAZEPINE 200MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2022-10-14Labeling · Supplement 18 · standard — Letter ↗AP
2016-09-23Efficacy · Supplement 11 · standard — Letter ↗AP
2016-09-23Efficacy · Supplement 12 · standard — Letter ↗AP
2012-11-13Labeling · Supplement 9 · standard — Letter ↗AP
2012-01-27REMS · Supplement 13 — Letter ↗AP
2010-10-24Labeling · Supplement 8 · standard — Label ↗AP
2009-04-23Labeling · Supplement 6 · 901 required — Label ↗AP
2007-12-19Labeling · Supplement 5 · standard — Letter ↗AP
2006-12-09Labeling · Supplement 3 · standard — Label ↗AP
2004-12-10Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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