Product Details for: Follistim AQ Cartridge
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PRODUCT LABEL
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
300IU/0.36ML
Multi-Dose Cartridge
351(a)
Follistim AQ Cartridge
Rx
002
Injection
Subcutaneous
600IU/0.72ML
Multi-Dose Cartridge
351(a)
Follistim AQ Cartridge
Rx
003
Injection
Subcutaneous
175IU/0.21ML
Multi-Dose Cartridge
351(a)
Follistim AQ Cartridge
Disc
004
Injection
Subcutaneous
900IU/1.08ML
Multi-Dose Cartridge
351(a)
Follistim AQ Cartridge
Rx
Proper Name
follitropin beta
follitropin beta
BLA Number
021211
021211
Applicant
Organon USA LLC, a subsidiary of Organon & Co.
Organon USA LLC, a subsidiary of Organon & Co.
Original Approval Date
March 23, 2004
March 23, 2004
Date of First Licensure