APPLICATION
ANDA083982
TYPE
ANDA
ORIGINAL APPROVAL
1974-05-06
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROPYLTHIOURACILDiscontinued
PROPYLTHIOURACIL 50MG · TABLET · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 46AP
1994-12-23Manufacturing (CMC) · Supplement 45AP
1994-10-11Manufacturing (CMC) · Supplement 44AP
1992-04-03Manufacturing (CMC) · Supplement 43AP
1992-04-03Manufacturing (CMC) · Supplement 41AP
1990-06-05Labeling · Supplement 40AP
1988-10-28Labeling · Supplement 39AP
1988-02-22Manufacturing (CMC) · Supplement 38AP
1988-02-22Manufacturing (CMC) · Supplement 36AP
1988-02-22Manufacturing (CMC) · Supplement 37AP
1988-02-22Manufacturing (CMC) · Supplement 35AP
1987-04-06Manufacturing (CMC) · Supplement 34AP
1986-09-22Manufacturing (CMC) · Supplement 33AP
1985-10-08Manufacturing (CMC) · Supplement 32AP
1983-02-28Manufacturing (CMC) · Supplement 28AP
1983-02-28Manufacturing (CMC) · Supplement 27AP
1974-05-06OriginalAP
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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