Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Follistim AQ (follitropin beta) Injection, Organon, Approval | Gonal-f RFF (follitropin alfa for injection), Serono, Control Supplement | Gonal-f RFF (follitropin alfa) Injection, EMD Serono Inc., Labeling Revision | Gonal-f RFF Pen (follitropin alfa) Injection, EMD Serono, Manufacturing Change or Addition | Gonal-f RFF Pen (follitropin alfa) Injection, EMD Serono Inc., Labeling Revision | Follistim AQ (follitropin alfa and beta) Injection, Organon USA Inc., Package Change ^ FDA's latest approval appears at the bottom of this list. ^                                                                                      A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2009 Betterchem.com