MedPath

Fyremadel

Fyremadel (ganirelix acetate) injection

Approved
Approval ID

5f0908b5-3551-47fd-95f7-3669b0dff7f1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 26, 2023

Manufacturers
FDA

Ferring Pharmaceuticals Inc.

DUNS: 103722955

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 Code55566-1010
Application NumberANDA204246
Product Classification
M
Marketing Category
C73584
G
Generic Name
ganirelix acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 26, 2023
FDA Product Classification

INGREDIENTS (5)

WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
ganirelix acetateActive
Quantity: 250 ug in 0.5 mL
Code: 56U7906FQW
Classification: ACTIB
Acetic AcidInactive
Code: Q40Q9N063P
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT

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Fyremadel - FDA Drug Approval Details