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FDA Approval

Fyremadel

CompanyFerring Pharmaceuticals Inc. (DUNS: 103722955)

Effective Date

October 26, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ganirelix(250 ug in 0.5 mL)

Products (1)

Fyremadel

NDC Product Code

55566-1010

Application Number

ANDA204246

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS

Effective Date

October 26, 2023

Ingredients

WaterInactive

Code: 059QF0KO0RClass: IACT

Sodium HydroxideInactive

Code: 55X04QC32IClass: IACT

GanirelixActive

Code: 56U7906FQWClass: ACTIBQuantity: 250 ug in 0.5 mL

Acetic AcidInactive

Code: Q40Q9N063PClass: IACT

MannitolInactive

Code: 3OWL53L36AClass: IACT

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