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FDA NDA · NDA020515

ZOLADEX

Sponsor: TERSERA

APPLICATION
NDA020515
TYPE
NDA
ORIGINAL APPROVAL
1995-12-18
LATEST ACTION
2026-05-06
ROUTE
IMPLANTATION
DOSAGE FORM
IMPLANT
MARKETING STATUS
Prescription

Products

ZOLADEXPrescription
GOSERELIN 3.6MG · IMPLANT · IMPLANTATION

Approval history

2026-05-06Labeling · Supplement 13 · standardLetterAP
2025-09-23Labeling · Supplement 11 · standardLabelAP
1995-12-18Type 6 - New Indication (no longer used) · Original · standardAP
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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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