CAMCEVI
These highlights do not include all the information needed to use CAMCEVI safely and effectively. See full prescribing information for CAMCEVI.
Approved
Approval ID
cbff25e5-6fe8-4e44-b10a-8397b3349905
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 25, 2025
Manufacturers
FDA
Accord BioPharma, Inc.
DUNS: 079636487
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LEUPROLIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69448-023
Application NumberNDA211488
Product Classification
M
Marketing Category
C73594
G
Generic Name
LEUPROLIDE
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 25, 2025
FDA Product Classification
INGREDIENTS (3)
POLYLACTIDEInactive
Quantity: 184 mg in 0.37 g
Code: 459TN2L5F5
Classification: IACT
METHYLPYRROLIDONEInactive
Quantity: 136 mg in 0.37 g
Code: JR9CE63FPM
Classification: IACT
LEUPROLIDE MESYLATEActive
Quantity: 42 mg in 0.37 g
Code: 8E3C3C493W
Classification: ACTIM