← FDA DRUG APPROVALS

FDA ANDA · ANDA086423

DITATE-DS

Sponsor: SAVAGE LABS

APPLICATION
ANDA086423
TYPE
ANDA
LATEST ACTION
1986-11-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DITATE-DSDiscontinued
ESTRADIOL VALERATE 8MG/ML, TESTOSTERONE ENANTHATE 180MG/ML · INJECTABLE · INJECTION

Approval history

1986-11-28Manufacturing (CMC) · Supplement 15AP
1986-10-16Manufacturing (CMC) · Supplement 13AP
1984-09-10Manufacturing (CMC) · Supplement 10AP
1984-09-10Manufacturing (CMC) · Supplement 9AP
1983-01-13Manufacturing (CMC) · Supplement 7AP
1982-06-29Manufacturing (CMC) · Supplement 6AP
1982-06-29Manufacturing (CMC) · Supplement 5AP
1982-06-29Manufacturing (CMC) · Supplement 1AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →