← FDA DRUG APPROVALS

FDA NDA · NDA020021

SUDAFED 24 HOUR

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APPLICATION
NDA020021
TYPE
NDA
ORIGINAL APPROVAL
1992-12-15
LATEST ACTION
2018-11-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

SUDAFED 24 HOUR · ReferenceDiscontinued
PSEUDOEPHEDRINE HYDROCHLORIDE 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2018-11-13Labeling · Supplement 12 · standard — Label ↗AP
2017-12-21Labeling · Supplement 11 · standardAP
2001-10-24Manufacturing (CMC) · Supplement 6 · standard — Review ↗AP
2001-03-28Manufacturing (CMC) · Supplement 5 · standard — Review ↗AP
1998-08-05Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
1995-05-09Labeling · Supplement 3 · standard — Review ↗AP
1993-05-21Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1993-02-01Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1992-12-15Type 3 - New Dosage Form · Original · standardAP
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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