ZOLADEX
These highlights do not include all the information needed to use ZOLADEX safely and effectively. See full prescribing information for ZOLADEX.ZOLADEX (goserelin implant) 3.6 mgInitial U.S. Approval: 1989
Approved
Approval ID
294b168b-6e5f-4db9-bf70-d599271458b3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2023
Manufacturers
FDA
TerSera Therapeutics LLC
DUNS: 080226115
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
goserelin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70720-950
Application NumberNDA019726
Product Classification
M
Marketing Category
C73594
G
Generic Name
goserelin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 24, 2022
FDA Product Classification
INGREDIENTS (3)
goserelin acetateActive
Quantity: 3.6 mg in 1 1
Code: 6YUU2PV0U8
Classification: ACTIM
Glycolic AcidInactive
Code: 0WT12SX38S
Classification: IACT
Lactic Acid, DL-Inactive
Code: 3B8D35Y7S4
Classification: IACT