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FDA NDA · NDA208956

TRIPTODUR

triptorelin

Sponsor: AZURITY

APPLICATION
NDA208956
TYPE
NDA
ORIGINAL APPROVAL
2017-06-29
LATEST ACTION
2025-09-23
ROUTE
INTRAMUSCULAR
DOSAGE FORM
FOR SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

TRIPTODUR KIT · ReferencePrescription
TRIPTORELIN PAMOATE EQ 22.5MG BASE/VIAL · FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR

Approval history

2025-09-23Labeling · Supplement 14 · standard — Letter ↗AP
2022-12-07Labeling · Supplement 9 · standard — Letter ↗AP
2022-04-22Labeling · Supplement 10 · standard — Letter ↗AP
2019-10-04Labeling · Supplement 2 · standard — Letter ↗AP
2017-06-29Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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