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FDA ANDA · ANDA085603

TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE

Sponsor: WATSON LABS

APPLICATION
ANDA085603
TYPE
ANDA
ORIGINAL APPROVAL
1986-03-13
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATEDiscontinued
ESTRADIOL CYPIONATE 2MG/ML, TESTOSTERONE CYPIONATE 50MG/ML · INJECTABLE · INJECTION

Approval history

1999-02-19Manufacturing (CMC) · Supplement 18AP
1999-02-02Manufacturing (CMC) · Supplement 17AP
1998-04-15Manufacturing (CMC) · Supplement 16AP
1998-04-15Manufacturing (CMC) · Supplement 15AP
1996-12-31Labeling · Supplement 13AP
1996-08-28Manufacturing (CMC) · Supplement 14AP
1991-04-17Labeling · Supplement 12AP
1991-03-27Labeling · Supplement 11AP
1989-07-24Labeling · Supplement 10AP
1988-12-21Manufacturing (CMC) · Supplement 7AP
1988-06-14Labeling · Supplement 5AP
1986-07-17Manufacturing (CMC) · Supplement 3AP
1986-07-17Manufacturing (CMC) · Supplement 1AP
1986-03-13OriginalAP
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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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