APPLICATION
NDA018087
TYPE
NDA
ORIGINAL APPROVAL
1978-07-18
LATEST ACTION
1994-06-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
THYREL TRHDiscontinued
PROTIRELIN 0.5MG/ML · INJECTABLE · INJECTION
Approval history
1994-06-23Labeling · Supplement 13 · standardAP
1992-07-21Labeling · Supplement 12 · standardAP
1991-04-23Labeling · Supplement 11 · standardAP
1991-04-03Labeling · Supplement 10 · standardAP
1986-07-01Labeling · Supplement 8 · standardAP
1985-09-03Labeling · Supplement 7 · standardAP
1984-11-13Manufacturing (CMC) · Supplement 6 · standardAP
1983-07-28Manufacturing (CMC) · Supplement 4 · standardAP
1981-12-10Labeling · Supplement 5 · standardAP
1979-05-15Manufacturing (CMC) · Supplement 2 · standardAP
1978-07-18Type 5 - New Formulation or New Manufacturer · 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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