APPLICATION
ANDA087056
TYPE
ANDA
ORIGINAL APPROVAL
1980-01-10
LATEST ACTION
2009-03-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CYPROHEPTADINE HYDROCHLORIDE · ReferenceDiscontinued
CYPROHEPTADINE HYDROCHLORIDE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-10-04Manufacturing (CMC) · Supplement 36AP
2002-07-29Manufacturing (CMC) · Supplement 37AP
2001-09-12Manufacturing (CMC) · Supplement 35AP
2000-10-26Labeling · Supplement 34AP
2000-07-25Manufacturing (CMC) · Supplement 33AP
2000-01-28Manufacturing (CMC) · Supplement 32AP
1999-09-24Manufacturing (CMC) · Supplement 29AP
1999-09-24Manufacturing (CMC) · Supplement 31AP
1999-09-24Manufacturing (CMC) · Supplement 28AP
1999-08-20Manufacturing (CMC) · Supplement 30AP
1998-12-09Manufacturing (CMC) · Supplement 27AP
1998-03-10Manufacturing (CMC) · Supplement 25AP
1997-10-17Labeling · Supplement 26AP
1997-05-30Manufacturing (CMC) · Supplement 24AP
1994-10-13Manufacturing (CMC) · Supplement 22AP
1989-07-27Labeling · Supplement 21AP
1987-11-12Manufacturing (CMC) · Supplement 19AP
1987-11-12Manufacturing (CMC) · Supplement 20AP
1987-03-06Manufacturing (CMC) · Supplement 17AP
1984-03-08Manufacturing (CMC) · Supplement 16AP
1983-11-02Manufacturing (CMC) · Supplement 13AP
1982-11-12Manufacturing (CMC) · Supplement 12AP
1980-01-10OriginalAP
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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