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FDA NDA · NDA205474

OBREDON

Sponsor: SOVEREIGN PHARMS

APPLICATION
NDA205474
TYPE
NDA
ORIGINAL APPROVAL
2014-11-14
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

OBREDON · ReferenceDiscontinued
GUAIFENESIN 200MG/5ML, HYDROCODONE BITARTRATE 2.5MG/5ML · SOLUTION · ORAL

Approval history

2025-12-22Labeling · Supplement 9 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 8 · standard — Label ↗AP
2018-06-28Labeling · Supplement 5 · standard — Label ↗AP
2017-01-13Labeling · Supplement 3 · standard — Label ↗AP
2015-06-19Manufacturing (CMC) · Supplement 1 · standardAP
2014-11-14Type 4 - New Combination · Original · standard — Summary Review ↗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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