FDA Approval Activities for this Drug…

Follistim (Follitropin Beta) Injection, , 2/7/2002 Organon, NDA 20-582/S6 2/7/02 3/7/02 2/19/02 Follistim Indications: Follistim is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure. Follistim Organon NDA 020582/S002 03/26/99 8/11/03 Follistim Organon NDA 020582/S001 Gonal-F (follitropin alfa) Injection, Serono, NDA 20-378/S26 & S29 7/16/03 7/28/03 Gonal-F (follitropin alfa) Injection, Serono NDA 20-378/S-006 5/24/00 5/31/00 Gonal-F Indications: for the induction of spermatogenesis in men with primary and secondary hopygonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure. FOLLITROPIN ALFA Injection 1,200 IU/VIAL GONAL-F SERONO 020582 BX FOLLITROPIN ALFA/BETA Injection 150 IU/VIAL FOLLISTIM ORGANON USA INC 020582 BX FOLLITROPIN ALFA/BETA Injection 75 IU/VIAL FOLLISTIM ORGANON USA INC 020378 BX FOLLITROPIN ALFA/BETA Injection 150 IU/VIAL GONAL-F SERONO 020378 BX FOLLITROPIN ALFA/BETA Injection 75 IU/VIAL GONAL-F SERONO 021289 BX UROFOLLITROPIN Intramuscular, Subcutaneous 75 IU/VIAL BRAVELLE FERRING 019415 BX UROFOLLITROPIN Subcutaneous 75 IU/AMP FERTINEX SERONO Follistim-AQ Cartridge (follitropin beta injection), Organon Inc. Gonal-F (follitropin alfa) Injection, Serono Inc. (follitropin alfa for injection), Serono, Inc. Gonal-f RFF Pen (follitropin alfa injection), Serono, Inc. | Follistim AQ Cartridge (follitropin beta injection), Organon, Inc., Control Supplement

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