APPLICATION
ANDA085239
TYPE
ANDA
ORIGINAL APPROVAL
1979-02-21
LATEST ACTION
2017-11-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ESTRONEDiscontinued
ESTRONE 5MG/ML · INJECTABLE · INJECTION
Approval history
2017-11-03Labeling · Supplement 61 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 59AP
1999-02-02Manufacturing (CMC) · Supplement 58AP
1998-05-13Manufacturing (CMC) · Supplement 57AP
1996-08-20Labeling · Supplement 56AP
1991-05-01Labeling · Supplement 55AP
1991-03-28Labeling · Supplement 54AP
1991-02-22Manufacturing (CMC) · Supplement 52AP
1991-02-22Manufacturing (CMC) · Supplement 53AP
1989-08-28Labeling · Supplement 62AP
1989-08-28Labeling · Supplement 51AP
1988-12-28Manufacturing (CMC) · Supplement 50AP
1988-12-28Manufacturing (CMC) · Supplement 49AP
1988-03-01Manufacturing (CMC) · Supplement 44AP
1986-05-01Manufacturing (CMC) · Supplement 40AP
1983-08-24Manufacturing (CMC) · Supplement 38AP
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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