← FDA DRUG APPROVALS

FDA NDA · NDA018658

DELSYM

dextromethorphan

Sponsor: RECKITT BENCKISER

APPLICATION
NDA018658
TYPE
NDA
ORIGINAL APPROVAL
1982-10-08
LATEST ACTION
2024-03-15
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

DELSYM · ReferenceOver-the-counter
DEXTROMETHORPHAN POLISTIREX EQ 30MG HYDROBROMIDE/5ML · SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2024-03-15Labeling · Supplement 34 · standard — Letter ↗AP
2019-09-23Manufacturing (CMC) · Supplement 31 — Letter ↗AP
2014-06-19Labeling · Supplement 30 · standard — Label ↗AP
2011-05-16Labeling · Supplement 29 · standard — Letter ↗AP
2010-11-10Manufacturing (CMC) · Supplement 28 · standard — Letter ↗AP
2010-04-08Labeling · Supplement 27 · standard — Letter ↗AP
2009-10-08Labeling · Supplement 26 · standard — Letter ↗AP
2008-12-05Labeling · Supplement 23 · standard — Letter ↗AP
2007-09-28Manufacturing (CMC) · Supplement 22 — Letter ↗AP
2005-03-08Manufacturing (CMC) · Supplement 18 · standard — Letter ↗AP
2004-11-10Manufacturing (CMC) · Supplement 17 · standard — Review ↗AP
2002-07-10Manufacturing (CMC) · Supplement 16 · standardAP
2002-01-24Labeling · Supplement 15 · standard — Letter ↗AP
2001-02-15Labeling · Supplement 14 · standardAP
1999-11-08Manufacturing (CMC) · Supplement 12 · standardAP
1999-08-09Manufacturing (CMC) · Supplement 13 · standardAP
1993-10-26Labeling · Supplement 10AP
1993-10-26Manufacturing (CMC) · Supplement 9 · standardAP
1993-08-10Manufacturing (CMC) · Supplement 8 · standardAP
1992-12-28Manufacturing (CMC) · Supplement 11 · standardAP
1986-10-09Manufacturing (CMC) · Supplement 7 · standardAP
1985-06-12Manufacturing (CMC) · Supplement 5 · standardAP
1985-05-10Manufacturing (CMC) · Supplement 2 · standardAP
1984-06-11Labeling · Supplement 1AP
1984-06-11Labeling · Supplement 4AP
1982-10-08Type 3 - New Dosage Form · Original · standardAP
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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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