← FDA DRUG APPROVALS

FDA NDA · NDA021282

MUCINEX

guaifenesin

Sponsor: RECKITT BENCKISER

APPLICATION
NDA021282
TYPE
NDA
ORIGINAL APPROVAL
2002-07-12
LATEST ACTION
2024-08-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

MUCINEX · ReferenceOver-the-counter
GUAIFENESIN 600MG · TABLET, EXTENDED RELEASE · ORAL
MUCINEX · ReferenceOver-the-counter
GUAIFENESIN 1.2GM · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-08-30Labeling · Supplement 55 · standard — Label ↗AP
2021-02-19Labeling · Supplement 54 · standard — Label ↗AP
2020-04-02Manufacturing (CMC) · Supplement 51 — Letter ↗AP
2017-10-27Manufacturing (CMC) · Supplement 49 — Label ↗AP
2017-07-03Manufacturing (CMC) · Supplement 48 · standard — Label ↗AP
2015-10-19Manufacturing (CMC) · Supplement 46 · standard — Letter ↗AP
2015-03-09Manufacturing (CMC) · Supplement 45 · standard — Letter ↗AP
2014-09-10Manufacturing (CMC) · Supplement 44 · standard — Letter ↗AP
2014-05-22Manufacturing (CMC) · Supplement 43 · standard — Letter ↗AP
2011-05-12Manufacturing (CMC) · Supplement 37 · standard — Letter ↗AP
2011-03-11Manufacturing (CMC) · Supplement 35 · standard — Letter ↗AP
2009-11-24Manufacturing (CMC) · Supplement 31 — Letter ↗AP
2009-04-03Manufacturing (CMC) · Supplement 29 · standard — Letter ↗AP
2008-08-20Manufacturing (CMC) · Supplement 25 — Letter ↗AP
2007-09-06Manufacturing (CMC) · Supplement 21 — Label ↗AP
2006-11-14Labeling · Supplement 16 · standard — Letter ↗AP
2006-08-23Manufacturing (CMC) · Supplement 11 — Letter ↗AP
2002-12-18Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2002-07-12Type 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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