What is DITATE-DS used for?

DITATE-DS is an FDA-approved medication. See full prescribing information for approved uses.

Is DITATE-DS FDA approved?

Yes, DITATE-DS is FDA approved (first approved 1982-06-29) and manufactured by SAVAGE LABS.

DITATE-DS is manufactured by SAVAGE LABS.

Data updated: Mar 10, 2026

DITATE-DS

ESTRADIOL VALERATE

Approved 1982-06-29

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Details

Status: Discontinued
First Approved: 1982-06-29
Routes: INJECTION
Dosage Forms: INJECTABLE

Companies

SAVAGE LABS

Active Ingredient: ESTRADIOL VALERATE , TESTOSTERONE ENANTHATE

DITATE-DS Approval History

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

Understanding FDA Approval Types

Count	Type	What it means
-	ORIG	Original approval - drug first enters market
-	SUPPL - Efficacy	New indication (new disease/condition approved)
-	SUPPL - Labeling	Label text changes (warnings, dosing updates)
-	SUPPL - Manufacturing	Production changes (new facility)
-	SUPPL - Chemistry	Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DITATE-DS FDA Label Details

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Data Sources

FDA Approval: ANDA086423 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.