APPLICATION
NDA003977
TYPE
NDA
ORIGINAL APPROVAL
1941-06-12
LATEST ACTION
1996-03-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
THEELINDiscontinued
ESTRONE 2MG/ML · INJECTABLE · INJECTION
THEELINDiscontinued
ESTRONE 5MG/ML · INJECTABLE · INJECTION
THEELINDiscontinued
ESTRONE 1MG/ML · INJECTABLE · INJECTION
Approval history
1996-03-27Labeling · Supplement 3AP
1996-03-27Labeling · Supplement 6AP
1996-03-27Labeling · Supplement 2AP
1988-07-19Labeling · Supplement 13AP
1988-05-17Labeling · Supplement 12AP
1987-12-29Labeling · Supplement 10AP
1987-04-07Labeling · Supplement 8AP
1986-09-29Labeling · Supplement 7AP
1978-10-20Labeling · Supplement 4AP
1941-06-12UNKNOWN · Original · unknownAP
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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