APPLICATION
ANDA083714
TYPE
ANDA
ORIGINAL APPROVAL
1979-02-28
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ESTRADIOL VALERATEDiscontinued
ESTRADIOL VALERATE 40MG/ML · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 64AP
1999-02-02Manufacturing (CMC) · Supplement 62AP
1998-09-25Manufacturing (CMC) · Supplement 63AP
1997-01-17Manufacturing (CMC) · Supplement 61AP
1996-08-16Labeling · Supplement 60AP
1991-10-01Labeling · Supplement 59AP
1991-05-01Labeling · Supplement 58AP
1991-03-15Labeling · Supplement 56AP
1991-02-07Manufacturing (CMC) · Supplement 54AP
1990-12-18Labeling · Supplement 57AP
1988-10-28Manufacturing (CMC) · Supplement 52AP
1988-10-28Manufacturing (CMC) · Supplement 53AP
1986-05-02Manufacturing (CMC) · Supplement 45AP
1984-09-05Manufacturing (CMC) · Supplement 44AP
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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