← FDA DRUG APPROVALS

FDA ANDA · ANDA205781

TESTOSTERONE

Sponsor: PADAGIS ISRAEL

APPLICATION
ANDA205781
TYPE
ANDA
ORIGINAL APPROVAL
2017-07-12
LATEST ACTION
2019-06-27
ROUTE
TOPICAL, TRANSDERMAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

TESTOSTERONEPrescription
TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) · GEL · TRANSDERMAL
TESTOSTERONEPrescription
TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) · GEL · TRANSDERMAL

Approval history

2019-06-27Labeling · Supplement 4 · standardAP
2017-07-12UNKNOWN · Original · standardLetterAP
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 →