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FDA NDA · NDA006188

PROPYLTHIOURACIL

Sponsor: PH HEALTH

APPLICATION
NDA006188
TYPE
NDA
ORIGINAL APPROVAL
1947-07-28
LATEST ACTION
2018-09-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PROPYLTHIOURACIL · ReferencePrescription
PROPYLTHIOURACIL 50MG · TABLET · ORAL

Approval history

2018-09-19Labeling · Supplement 26 · 901 required — Label ↗AP
2016-01-15Labeling · Supplement 25 · standard — Letter ↗AP
2015-02-10Labeling · Supplement 24 · standard — Label ↗AP
2013-12-19Manufacturing (CMC) · Supplement 23AP
2011-07-27Labeling · Supplement 21 · unknown — Letter ↗AP
2011-07-27REMS · Supplement 22 — Letter ↗AP
2010-04-01Labeling · Supplement 20 · 901 order — Label ↗AP
2001-10-01Labeling · Supplement 19 · standard — Label ↗AP
2001-10-01Labeling · Supplement 18 · standard — Label ↗AP
1999-03-11Manufacturing (CMC) · Supplement 17AP
1996-04-26Manufacturing (CMC) · Supplement 16AP
1996-04-01Manufacturing (CMC) · Supplement 15AP
1990-06-29Labeling · Supplement 14AP
1987-12-04Manufacturing (CMC) · Supplement 11AP
1986-01-15Labeling · Supplement 10AP
1980-10-31Manufacturing (CMC) · Supplement 5AP
1980-10-31Manufacturing (CMC) · Supplement 6AP
1947-07-28UNKNOWN · Original · unknownAP
VIEW ON DRUGS@FDA ↗

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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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