Ganirelix Acetate
Ganirelix Acetate Injection(For Subcutaneous Use Only)
Approved
Approval ID
1f067dfb-f9c7-4020-ab7b-da2ba695ab32
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2023
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
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 Code71288-554
Application NumberANDA214996
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ganirelix Acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJune 6, 2022
FDA Product Classification
INGREDIENTS (5)
ganirelix acetateActive
Quantity: 250 ug in 0.5 mL
Code: 56U7906FQW
Classification: ACTIB
mannitolInactive
Quantity: 23.5 mg in 0.5 mL
Code: 3OWL53L36A
Classification: IACT
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