← FDA DRUG APPROVALS

FDA ANDA · ANDA073585

SUDAFED 12 HOUR

Sponsor: MCNEIL CONS

APPLICATION
ANDA073585
TYPE
ANDA
ORIGINAL APPROVAL
1991-10-31
LATEST ACTION
2019-01-15
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

SUDAFED 12 HOURDiscontinued
PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2019-01-15Labeling · Supplement 20 · standardAP
2018-11-14Labeling · Supplement 19 · standardAP
2001-11-06Labeling · Supplement 14AP
2000-09-11Manufacturing (CMC) · Supplement 13AP
1999-07-12Manufacturing (CMC) · Supplement 9AP
1999-07-12Manufacturing (CMC) · Supplement 12AP
1999-07-12Manufacturing (CMC) · Supplement 7AP
1999-07-12Manufacturing (CMC) · Supplement 10AP
1999-07-12Labeling · Supplement 5AP
1999-07-12Manufacturing (CMC) · Supplement 8AP
1999-07-12Manufacturing (CMC) · Supplement 11AP
1999-07-12Manufacturing (CMC) · Supplement 6AP
1997-01-31Labeling · Supplement 4AP
1991-10-31Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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