APPLICATION
NDA017638
TYPE
NDA
ORIGINAL APPROVAL
1976-11-05
LATEST ACTION
1991-11-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
THYPINONEDiscontinued
PROTIRELIN 0.5MG/ML · INJECTABLE · INJECTION
Approval history
1991-11-25Labeling · Supplement 11 · priorityAP
1991-06-07Labeling · Supplement 10 · priorityAP
1990-02-14Labeling · Supplement 9 · priorityAP
1986-03-24Labeling · Supplement 7 · priorityAP
1985-07-16Manufacturing (CMC) · Supplement 6 · priorityAP
1982-02-09Manufacturing (CMC) · Supplement 3 · priorityAP
1977-07-12Manufacturing (CMC) · Supplement 1 · priorityAP
1976-11-05Type 1 - New Molecular Entity · Original · priorityAP
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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