APPLICATION
ANDA080154
TYPE
ANDA
ORIGINAL APPROVAL
1971-07-23
LATEST ACTION
2021-03-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PROPYLTHIOURACILPrescription
PROPYLTHIOURACIL 50MG · TABLET · ORAL
Approval history
2021-03-18Manufacturing (CMC) · Supplement 44 · unknownAP
2020-08-26Labeling · Supplement 43 · standardAP
2016-11-30Labeling · Supplement 42 · standardAP
2016-11-30Labeling · Supplement 39 · standardAP
2011-08-22Labeling · Supplement 37AP
2010-12-29Labeling · Supplement 36AP
2002-11-21Labeling · Supplement 32AP
2002-03-12Manufacturing (CMC) · Supplement 30AP
2001-06-28Manufacturing (CMC) · Supplement 29AP
2001-03-12Manufacturing (CMC) · Supplement 28AP
1999-02-17Labeling · Supplement 26AP
1999-02-17Manufacturing (CMC) · Supplement 25AP
1998-10-01Manufacturing (CMC) · Supplement 27AP
1995-01-31Manufacturing (CMC) · Supplement 18AP
1995-01-31Labeling · Supplement 22AP
1995-01-31Manufacturing (CMC) · Supplement 20AP
1995-01-31Manufacturing (CMC) · Supplement 19AP
1995-01-31Manufacturing (CMC) · Supplement 17AP
1985-11-19Manufacturing (CMC) · Supplement 14AP
1984-11-19Manufacturing (CMC) · Supplement 13AP
1983-01-26Manufacturing (CMC) · Supplement 7AP
1971-07-23OriginalAP
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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