APPLICATION
NDA010562
TYPE
NDA
ORIGINAL APPROVAL
1956-07-25
LATEST ACTION
1996-03-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYDELTRA-TBADiscontinued
PREDNISOLONE TEBUTATE 20MG/ML · INJECTABLE · INJECTION
Approval history
1996-03-01Manufacturing (CMC) · Supplement 31 · standardAP
1993-08-26Labeling · Supplement 29 · standardAP
1989-12-11Manufacturing (CMC) · Supplement 28 · standardAP
1989-05-16Labeling · Supplement 23 · standardAP
1982-03-04Manufacturing (CMC) · Supplement 20 · standardAP
1982-03-04Manufacturing (CMC) · Supplement 21 · standardAP
1980-07-02Manufacturing (CMC) · Supplement 17 · standardAP
1979-08-15Labeling · Supplement 18 · standardAP
1979-08-08Labeling · Supplement 16 · standardAP
1979-08-08Labeling · Supplement 14 · standardAP
1979-08-08Labeling · Supplement 15 · standardAP
1956-07-25Type 2 - New Active Ingredient · 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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