APPLICATION
NDA017603
TYPE
NDA
ORIGINAL APPROVAL
1975-08-29
LATEST ACTION
1996-06-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
NOVAFEDDiscontinued
PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1996-06-21Labeling · Supplement 33 · standardAP
1992-06-24Manufacturing (CMC) · Supplement 32 · standardAP
1992-04-06Manufacturing (CMC) · Supplement 30 · standardAP
1984-06-06Manufacturing (CMC) · Supplement 26 · standardAP
1983-06-09Labeling · Supplement 25 · standardAP
1982-02-02Labeling · Supplement 24 · standardAP
1981-10-23Labeling · Supplement 23 · standardAP
1981-10-09Manufacturing (CMC) · Supplement 22 · standardAP
1981-06-09Labeling · Supplement 19 · standardAP
1981-04-29Manufacturing (CMC) · Supplement 20 · standardAP
1980-09-15Labeling · Supplement 18 · standardAP
1980-07-03Labeling · Supplement 16 · standardAP
1980-07-03Manufacturing (CMC) · Supplement 15 · standardAP
1979-11-09Labeling · Supplement 17 · standardAP
1978-08-11Labeling · Supplement 12 · standardAP
1978-05-02Labeling · Supplement 13 · standardAP
1978-02-06Labeling · Supplement 14 · standardAP
1977-02-11Labeling · Supplement 10 · standardAP
1977-01-18Labeling · Supplement 9 · standardAP
1977-01-18Manufacturing (CMC) · Supplement 6 · standardAP
1976-09-17Labeling · Supplement 8 · standardAP
1976-09-07Labeling · Supplement 7 · standardAP
1976-06-17Manufacturing (CMC) · Supplement 5 · standardAP
1976-02-27Labeling · Supplement 3 · standardAP
1976-02-27Labeling · Supplement 4 · standardAP
1976-01-27Labeling · Supplement 2 · standardAP
1975-08-29Type 3 - New Dosage Form · Original · standardAP
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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