APPLICATION
NDA013220
TYPE
NDA
ORIGINAL APPROVAL
1962-03-30
LATEST ACTION
1996-06-21
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PERIACTIN · ReferenceDiscontinued
CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL
Approval history
1996-06-21Labeling · Supplement 41 · standardAP
1992-10-16Manufacturing (CMC) · Supplement 38 · standardAP
1992-08-05Labeling · Supplement 39 · standardAP
1989-10-11Manufacturing (CMC) · Supplement 37 · standardAP
1986-11-04Manufacturing (CMC) · Supplement 35 · standardAP
1986-11-04Labeling · Supplement 33 · standardAP
1986-11-04Labeling · Supplement 36 · standardAP
1986-05-07Labeling · Supplement 34 · standardAP
1985-10-01Manufacturing (CMC) · Supplement 32 · standardAP
1984-05-16Labeling · Supplement 31 · standardAP
1984-04-30Manufacturing (CMC) · Supplement 30 · standardAP
1983-04-22Labeling · Supplement 29 · standardAP
1981-05-04Manufacturing (CMC) · Supplement 28 · standardAP
1980-04-04Manufacturing (CMC) · Supplement 27 · standardAP
1980-04-04Manufacturing (CMC) · Supplement 26 · standardAP
1979-08-01Labeling · Supplement 25 · standardAP
1979-05-29Manufacturing (CMC) · Supplement 24 · standardAP
1978-10-30Labeling · Supplement 23 · standardAP
1962-03-30Type 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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