ZOLADEX
These highlights do not include all the information needed to use ZOLADEX safely and effectively. See full prescribing information for ZOLADEX.ZOLADEX (goserelin acetate implant) 3.6 mgInitial U.S. Approval: 1989
Approved
Approval ID
a906a5bd-d2ec-4e35-8962-c0c86c637630
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 16, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
goserelin acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-3466
Application NumberNDA019726
Product Classification
M
Marketing Category
C73594
G
Generic Name
goserelin acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJune 29, 2018
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