APPLICATION
NDA018104
TYPE
NDA
ORIGINAL APPROVAL
1982-12-29
LATEST ACTION
1990-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYLORELDiscontinued
GUANADREL SULFATE 10MG · TABLET · ORAL
HYLORELDiscontinued
GUANADREL SULFATE 25MG · TABLET · ORAL
Approval history
1990-08-01Labeling · Supplement 6AP
1990-08-01Labeling · Supplement 7AP
1986-10-07Manufacturing (CMC) · Supplement 5 · standardAP
1985-08-20Labeling · Supplement 3AP
1985-08-20Labeling · Supplement 4AP
1983-09-13Manufacturing (CMC) · Supplement 2 · standardAP
1983-04-01Labeling · Supplement 1AP
1982-12-29Type 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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