← FDA DRUG APPROVALS

FDA NDA · NDA021620

MUCINEX DM MAXIMUM STRENGTH

guaifenesin and dextromethorphan hydrobromide

Sponsor: RECKITT BENCKISER

APPLICATION
NDA021620
TYPE
NDA
ORIGINAL APPROVAL
2004-04-29
LATEST ACTION
2024-08-06
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

MUCINEX DM · ReferenceOver-the-counter
DEXTROMETHORPHAN HYDROBROMIDE 60MG, GUAIFENESIN 1.2GM · TABLET, EXTENDED RELEASE · ORAL
MUCINEX DM · ReferenceOver-the-counter
DEXTROMETHORPHAN HYDROBROMIDE 30MG, GUAIFENESIN 600MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-08-06Labeling · Supplement 45 · standard — Letter ↗AP
2021-02-19Labeling · Supplement 43 · standard — Label ↗AP
2020-01-31Manufacturing (CMC) · Supplement 40 — Letter ↗AP
2019-01-03Manufacturing (CMC) · Supplement 39 — Letter ↗AP
2017-07-13Manufacturing (CMC) · Supplement 38 · standard — Letter ↗AP
2015-04-07Manufacturing (CMC) · Supplement 37 · standardAP
2014-09-05Manufacturing (CMC) · Supplement 36 · standardAP
2011-05-12Manufacturing (CMC) · Supplement 31 · standard — Letter ↗AP
2011-03-11Manufacturing (CMC) · Supplement 29 · standard — Letter ↗AP
2009-04-03Manufacturing (CMC) · Supplement 21 — Letter ↗AP
2007-09-06Manufacturing (CMC) · Supplement 11 — Label ↗AP
2006-01-26Manufacturing (CMC) · Supplement 5 · standard — Letter ↗AP
2005-01-24Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2004-04-29Type 5 - New Formulation or New Manufacturer · 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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