← FDA DRUG APPROVALS

FDA NDA · NDA211488

CAMCEVI

leuprolide

Sponsor: ACCORD

APPLICATION
NDA211488
TYPE
NDA
ORIGINAL APPROVAL
2021-05-25
LATEST ACTION
2026-02-11
ROUTE
SUBCUTANEOUS
DOSAGE FORM
EMULSION
MARKETING STATUS
Prescription

Products

CAMCEVI KIT · ReferencePrescription
LEUPROLIDE MESYLATE EQ 42MG BASE · EMULSION · SUBCUTANEOUS

Approval history

2026-02-11Labeling · Supplement 11 · standard — Letter ↗AP
2025-09-23Labeling · Supplement 10 · standard — Letter ↗AP
2025-02-11Labeling · Supplement 6 · standard — Letter ↗AP
2024-03-13Labeling · Supplement 4 · standard — Letter ↗AP
2021-05-25Type 2 - New Active Ingredient · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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.

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