APPLICATION
ANDA086833
TYPE
ANDA
ORIGINAL APPROVAL
1980-04-16
LATEST ACTION
2000-10-02
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
CYPROHEPTADINE HYDROCHLORIDE · ReferenceDiscontinued
CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL
Approval history
2000-10-02Manufacturing (CMC) · Supplement 27AP
1997-09-29Labeling · Supplement 25AP
1990-09-28Manufacturing (CMC) · Supplement 24AP
1990-04-05Labeling · Supplement 22AP
1989-12-26Labeling · Supplement 21AP
1989-11-06Labeling · Supplement 16AP
1989-10-11Labeling · Supplement 20AP
1989-03-03Manufacturing (CMC) · Supplement 18AP
1989-03-03Manufacturing (CMC) · Supplement 19AP
1989-03-03Manufacturing (CMC) · Supplement 17AP
1986-11-05Manufacturing (CMC) · Supplement 15AP
1983-04-11Manufacturing (CMC) · Supplement 12AP
1982-11-26Manufacturing (CMC) · Supplement 11AP
1982-11-22Manufacturing (CMC) · Supplement 10AP
1980-04-16OriginalAP
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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