APPLICATION
ANDA080172
TYPE
ANDA
ORIGINAL APPROVAL
1973-01-09
LATEST ACTION
2019-12-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PROPYLTHIOURACILPrescription
PROPYLTHIOURACIL 50MG · TABLET · ORAL
Approval history
2019-12-06Labeling · Supplement 60 · standardAP
2019-12-06Labeling · Supplement 57 · standardAP
2011-10-13REMS · Supplement 50AP
2011-10-11Labeling · Supplement 49AP
2011-01-21Labeling · Supplement 48AP
2010-12-15REMS · Supplement 46AP
2002-03-25Labeling · Supplement 33AP
2001-11-02Manufacturing (CMC) · Supplement 32AP
2000-12-11Manufacturing (CMC) · Supplement 31AP
1999-10-29Manufacturing (CMC) · Supplement 30AP
1996-01-18Manufacturing (CMC) · Supplement 29AP
1994-04-07Manufacturing (CMC) · Supplement 26AP
1994-04-07Manufacturing (CMC) · Supplement 27AP
1991-01-23Labeling · Supplement 25AP
1988-07-21Manufacturing (CMC) · Supplement 23AP
1988-05-23Labeling · Supplement 24AP
1987-07-16Manufacturing (CMC) · Supplement 22AP
1987-01-23Manufacturing (CMC) · Supplement 21AP
1985-02-20Manufacturing (CMC) · Supplement 18AP
1985-02-20Manufacturing (CMC) · Supplement 17AP
1983-07-26Manufacturing (CMC) · Supplement 14AP
1983-07-26Manufacturing (CMC) · Supplement 13AP
1973-01-09OriginalAP
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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