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) 10.8 mgInitial U.S. Approval: 1996
Approved
Approval ID
e4cb3c20-2738-400a-b522-3f36f71fe6c5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2022
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 Code70720-951
Application NumberNDA020578
Product Classification
M
Marketing Category
C73594
G
Generic Name
goserelin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 18, 2020
FDA Product Classification
INGREDIENTS (3)
Glycolic AcidInactive
Code: 0WT12SX38S
Classification: IACT
goserelin acetateActive
Quantity: 10.8 mg in 1 1
Code: 6YUU2PV0U8
Classification: ACTIM
Lactic Acid, DL-Inactive
Code: 3B8D35Y7S4
Classification: IACT