APPLICATION
ANDA087129
TYPE
ANDA
ORIGINAL APPROVAL
1981-07-09
LATEST ACTION
2002-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CYPROHEPTADINE HYDROCHLORIDEDiscontinued
CYPROHEPTADINE HYDROCHLORIDE 4MG · TABLET · ORAL
Approval history
2002-08-29Labeling · Supplement 19AP
2000-10-31Labeling · Supplement 18AP
1997-09-24Labeling · Supplement 17AP
1997-06-23Labeling · Supplement 16AP
1993-10-19Labeling · Supplement 15AP
1993-08-24Labeling · Supplement 21AP
1993-08-24Labeling · Supplement 14AP
1987-01-23Manufacturing (CMC) · Supplement 8AP
1984-01-13Manufacturing (CMC) · Supplement 5AP
1984-01-13Manufacturing (CMC) · Supplement 6AP
1983-05-10Manufacturing (CMC) · Supplement 4AP
1983-05-10Manufacturing (CMC) · Supplement 2AP
1981-07-09OriginalAP
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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