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FDA NDA · NDA021585

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor: RECKITT BENCKISER

APPLICATION
NDA021585
TYPE
NDA
ORIGINAL APPROVAL
2004-06-22
LATEST ACTION
2024-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

MUCINEX D · ReferenceOver-the-counter
GUAIFENESIN 600MG, PSEUDOEPHEDRINE HYDROCHLORIDE 60MG · TABLET, EXTENDED RELEASE · ORAL
MUCINEX D · ReferenceOver-the-counter
GUAIFENESIN 1.2GM, PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-07-08Labeling · Supplement 38 · standard — Label ↗AP
2017-07-13Manufacturing (CMC) · Supplement 33 · standard — Letter ↗AP
2014-05-22Manufacturing (CMC) · Supplement 30 — Letter ↗AP
2013-08-02Manufacturing (CMC) · Supplement 29 · standardAP
2011-05-12Manufacturing (CMC) · Supplement 26 · standard — Letter ↗AP
2010-12-20Manufacturing (CMC) · Supplement 25 · standard — Letter ↗AP
2007-09-06Manufacturing (CMC) · Supplement 12 — Letter ↗AP
2005-02-23Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2005-01-24Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
2004-06-22Type 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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