APPLICATION
NDA012649
TYPE
NDA
ORIGINAL APPROVAL
1961-10-17
LATEST ACTION
2000-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PERIACTIN · ReferenceDiscontinued
CYPROHEPTADINE HYDROCHLORIDE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2000-02-25Labeling · Supplement 47 · standardAP
1996-06-21Labeling · Supplement 45 · standardAP
1995-01-04Manufacturing (CMC) · Supplement 43 · standardAP
1994-12-19Manufacturing (CMC) · Supplement 42 · standardAP
1992-08-05Labeling · Supplement 41 · standardAP
1992-07-21Manufacturing (CMC) · Supplement 39 · standardAP
1989-10-06Manufacturing (CMC) · Supplement 40 · standardAP
1986-11-04Labeling · Supplement 38 · standardAP
1986-11-04Labeling · Supplement 34 · standardAP
1986-11-04Manufacturing (CMC) · Supplement 37 · standardAP
1986-05-07Labeling · Supplement 36 · standardAP
1985-10-01Manufacturing (CMC) · Supplement 35 · standardAP
1984-05-16Labeling · Supplement 33 · standardAP
1984-04-30Manufacturing (CMC) · Supplement 32 · standardAP
1983-04-22Labeling · Supplement 31 · standardAP
1981-05-26Manufacturing (CMC) · Supplement 30 · standardAP
1981-05-04Manufacturing (CMC) · Supplement 29 · standardAP
1980-08-13Manufacturing (CMC) · Supplement 28 · standardAP
1979-06-20Labeling · Supplement 27 · standardAP
1979-03-19Manufacturing (CMC) · Supplement 26 · standardAP
1978-10-30Labeling · Supplement 25 · standardAP
1978-10-30Manufacturing (CMC) · Supplement 24 · standardAP
1961-10-17Type 1 - New Molecular Entity · 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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