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FDA ANDA · ANDA204268

TESTOSTERONE

Sponsor: PADAGIS ISRAEL

APPLICATION
ANDA204268
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-04
LATEST ACTION
2019-06-27
ROUTE
TOPICAL, TRANSDERMAL
DOSAGE FORM
GEL, METERED
MARKETING STATUS
Prescription

Products

TESTOSTERONEPrescription
TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) · GEL, METERED · TRANSDERMAL

Approval history

2019-06-27Labeling · Supplement 4 · standardAP
2015-08-04UNKNOWN · OriginalLetterAP
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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.

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