← FDA DRUG APPROVALS
FDA ANDA · ANDA085865
TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE
Sponsor: WATSON LABS
APPLICATION
ANDA085865
TYPE
ANDA
ORIGINAL APPROVAL
1981-05-07
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATEDiscontinued
ESTRADIOL VALERATE 4MG/ML, TESTOSTERONE ENANTHATE 90MG/ML · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 35AP
1999-02-02Manufacturing (CMC) · Supplement 34AP
1997-12-08Manufacturing (CMC) · Supplement 33AP
1996-12-04Manufacturing (CMC) · Supplement 32AP
1996-08-20Labeling · Supplement 31AP
1991-09-20Manufacturing (CMC) · Supplement 28AP
1991-09-20Manufacturing (CMC) · Supplement 26AP
1991-09-20Manufacturing (CMC) · Supplement 27AP
1991-04-17Labeling · Supplement 30AP
1990-07-24Labeling · Supplement 29AP
1989-08-18Bioequivalence · Supplement 21AP
1986-04-30Manufacturing (CMC) · Supplement 20AP
1984-09-05Manufacturing (CMC) · Supplement 18AP
1982-11-01Manufacturing (CMC) · Supplement 16AP
1982-06-23Manufacturing (CMC) · Supplement 17AP
1982-06-04Manufacturing (CMC) · Supplement 15AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.