← FDA DRUG APPROVALS

FDA NDA · NDA208085

XTRELUS

Sponsor: ECI PHARMS LLC

APPLICATION
NDA208085
TYPE
NDA
ORIGINAL APPROVAL
2018-04-25
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

XTRELUS · ReferenceDiscontinued
GUAIFENESIN 400MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL

Approval history

2025-12-22Labeling · Supplement 3 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 2 · standard — Label ↗AP
2018-10-31Labeling · Supplement 1 · standard — Label ↗AP
2018-04-25Type 3 - New Dosage Form and Type 4 - New Combination · 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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