GANIRELIX ACETATE
Ganirelix Acetate Injection FOR SUBCUTANEOUS USE ONLY
Approved
Approval ID
cad7c09c-234b-4e73-b460-a1b1f7adc28d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GANIRELIX ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-472
Application NumberANDA215658
Product Classification
M
Marketing Category
C73584
G
Generic Name
GANIRELIX ACETATE
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (5)
MANNITOLInactive
Quantity: 23.5 mg in 0.5 mL
Code: 3OWL53L36A
Classification: IACT
GANIRELIX ACETATEActive
Quantity: 250 ug in 0.5 mL
Code: 56U7906FQW
Classification: ACTIB
ACETIC ACIDInactive
Quantity: 0.1 mg in 0.5 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT