APPLICATION
NDA012154
TYPE
NDA
ORIGINAL APPROVAL
1966-10-05
LATEST ACTION
2002-12-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
UREAPHILDiscontinued
UREA 40GM/VIAL · INJECTABLE · INJECTION
Approval history
2002-04-03Manufacturing (CMC) · Supplement 26 · standardAP
2002-04-03Manufacturing (CMC) · Supplement 25 · standardAP
2000-06-06Labeling · Supplement 24 · standardAP
1985-10-28Manufacturing (CMC) · Supplement 22 · standardAP
1982-04-28Manufacturing (CMC) · Supplement 20 · standardAP
1982-02-22Labeling · Supplement 19 · standardAP
1981-09-08Labeling · Supplement 21 · standardAP
1980-06-24Manufacturing (CMC) · Supplement 18 · standardAP
1980-05-29Manufacturing (CMC) · Supplement 17 · standardAP
1980-02-29Manufacturing (CMC) · Supplement 16 · standardAP
1978-10-11Manufacturing (CMC) · Supplement 14 · standardAP
1977-11-29Manufacturing (CMC) · Supplement 13 · standardAP
1977-09-02Manufacturing (CMC) · Supplement 12 · standardAP
1976-03-01Manufacturing (CMC) · Supplement 11 · standardAP
1966-10-05Type 3 - New Dosage Form · 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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