← FDA DRUG APPROVALS

FDA ANDA · ANDA212301

TESTOSTERONE

Sponsor: ENCUBE

APPLICATION
ANDA212301
TYPE
ANDA
ORIGINAL APPROVAL
2021-01-11
LATEST ACTION
2025-07-11
ROUTE
TOPICAL, TRANSDERMAL
DOSAGE FORM
SOLUTION, METERED
MARKETING STATUS
Prescription

Products

TESTOSTERONEPrescription
TESTOSTERONE 30MG/1.5ML ACTUATION · SOLUTION, METERED · TRANSDERMAL

Approval history

2025-07-11Labeling · Supplement 1 · standardAP
2021-01-11UNKNOWN · Original · standardAP
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 →