FDA Approval Activities for this Drug…

Genotropin (somatropin [rDNA origin] for injection), Pharmacia & Upjohn Company NDA 20-280/S-040 5/12/03 7/9/03 7/9/03 Genotropin (somatropin [rDNA origin] for injection), 1.5, 5.8, and 13.8 mg, Pharmacia & Upjohn Company NDA 20-280/S-038 3/28/03 4/15/03 Genotropin (somatropin [rDNA origin] ) Injection, Pharmacia & Upjohn Co. NDA 20-280/S-023 6/20/00 7/24/00 Genotropin Indication: For treatment of pediatric patients with Prader-Willi Syndrome. Genotropin (somatropin [rDNA origin]) Injection), Pharmacia & Upjohn Co. NDA 20-280/S-031 7/25/01 8/2/01 8/2/01 12/11/01 Humatrope [Somatropin, (rDNA origin) for injection], Lilly Research NDA 19-640/S-033 7/25/03 8/14/03 8/14/03 Humatrope [Somatropin, (rDNA origin) for injection], Lilly Research NDA 19-640/S-032 3/24/03 3/26/03 Humatrope [Somatropin, (rDNA origin) for injection], Lilly Research NDA 19-640/S-031 12/4/02 12/9/02 Humatrope [Somatropin, (rDNA origin) for injection], Eli Lilly and Co. NDA 19-640/S-025 Norditropin (somatropin [rDNA origin] injection) Cartridges,5mg/1.5mL, 10mg/1.5mL, & 15mg/1.5mL, Novo Nordisk NDA 21-148 6/20/00 7/24/00 7/24/00 Norditropin Indications: long-term treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone. Norditropin (somatropin [rDNA origin] injection) Cartridges,5mg/1.5mL, 10mg/1.5mL, & 15mg/1.5mL, Novo Nordisk NDA 21-148/S1 Nutropin AQ (somatropin [rDNA origin] injection), Genentech, NDA 20-522/S-017 4/22/02 5/2/02 4/22/02 Nutropin AQ (somatropin [rDNA origin] injection). Genentech, NDA 20-522/S-013 4/13/00 4/17/00 7/8/03 Nutropin AQ (somatropin [rDNA origin] injection). Genentech, NDA 20-522/S-009 12/2/99 12/29/99 Nutropin (somatropin [rDNA origin] injection)., Genentech, NDA 19-676/S16 4/13/00 4/17/00 7/8/03 Nutropin (somatropin [rDNA origin] injection). Genentech, NDA 19-676/S13 12/2/99 12/29/99 4/29/03 Nutropin Depot (somatropin [rDNA origin] injectable suspension), 13.5mg, 18.0mg, 22.5mg., Genentech, NDA 21-075 12/22/99 12/27/99 12/27/99 4/4/01 Nutropin Indication:The long-term treatment of growth failure due to a lack of adequate endogenous GH secretion for once- or twice-a-month administration.Saizen (somatropin [rDNA origin]) Injection, Serono, NDA 19-764/S-023 Serostim [somatropin (rDNA origin)] Injection, Serono, NDA 20-604/S-027 SOMATROPIN RECOMBINANT Injection 5MG/ML TEV-TROPIN BIO TECH GEN 020168 SOMATROPIN RECOMBINANT Injection 10MG/VIAL NUTROPIN GENENTECH 021075 SOMATROPIN RECOMBINANT Injection 13.5MG/VIAL NUTROPIN DEPOT GENENTECH 021075 SOMATROPIN RECOMBINANT Injection 18MG/VIAL NUTROPIN DEPOT GENENTECH 021075 SOMATROPIN RECOMBINANT Injection 22.5MG/VIAL NUTROPIN DEPOT GENENTECH 020522 SOMATROPIN RECOMBINANT Injection 5MG/ML NUTROPIN AQ GENENTECH 020522 BX SOMATROPIN RECOMBINANT Injection 5MG/ML NUTROPIN AQ PEN GENENTECH 020168 BX SOMATROPIN RECOMBINANT Injection 5MG/VIAL NUTROPIN GENENTECH 019640 SOMATROPIN RECOMBINANT Injection 12MG/VIAL HUMATROPE LILLY 019640 SOMATROPIN RECOMBINANT Injection 24MG/VIAL HUMATROPE LILLY 019640 BX SOMATROPIN RECOMBINANT Injection 5MG/VIAL HUMATROPE LILLY 019640 BX SOMATROPIN RECOMBINANT Injection 6MG/VIAL HUMATROPE LILLY 021148 SOMATROPIN RECOMBINANT Injection 10MG/1.5ML NORDITROPIN NOVO NORDISK 021148 SOMATROPIN RECOMBINANT Injection 15MG/1.5ML NORDITROPIN NOVO NORDISK 019721 BX SOMATROPIN RECOMBINANT Injection 4MG/VIAL NORDITROPIN NOVO NORDISK 021148 SOMATROPIN RECOMBINANT Injection 5MG/1.5ML NORDITROPIN NOVO NORDISK 019721 SOMATROPIN RECOMBINANT Injection 8MG/VIAL NORDITROPIN NOVO NORDISK 020280 SOMATROPIN RECOMBINANT Injection 0.2MG/VIAL GENOTROPIN PRESERVATIVE FREE PHARMACIA AND UPJOHN 020280 SOMATROPIN RECOMBINANT Injection 0.4MG/VIAL GENOTROPIN PRESERVATIVE FREE PHARMACIA AND UPJOHN 020280 SOMATROPIN RECOMBINANT Injection 0.6MG/VIAL GENOTROPIN PRESERVATIVE FREE PHARMACIA AND UPJOHN 020280 SOMATROPIN RECOMBINANT Injection 0.8MG/VIAL GENOTROPIN PRESERVATIVE FREE PHARMACIA AND UPJOHN 020280 SOMATROPIN RECOMBINANT Injection 1.2MG/VIAL GENOTROPIN PRESERVATIVE FREE PHARMACIA AND UPJOHN 020280 SOMATROPIN RECOMBINANT Injection 1.4MG/VIAL GENOTROPIN PRESERVATIVE FREE PHARMACIA AND UPJOHN 020280 SOMATROPIN RECOMBINANT Injection 1.5MG/VIAL GENOTROPIN PRESERVATIVE FREE PHARMACIA AND UPJOHN 020280 SOMATROPIN RECOMBINANT Injection 1.6MG/VIAL GENOTROPIN PRESERVATIVE FREE PHARMACIA AND UPJOHN 020280 SOMATROPIN RECOMBINANT Injection 1.8MG/VIAL GENOTROPIN PRESERVATIVE FREE PHARMACIA AND UPJOHN 020280 SOMATROPIN RECOMBINANT Injection 13.8MG/VIAL GENOTROPIN PHARMACIA AND UPJOHN 020280 SOMATROPIN RECOMBINANT Injection 1MG/VIAL GENOTROPIN PRESERVATIVE FREE PHARMACIA AND UPJOHN 020280 SOMATROPIN RECOMBINANT Injection 2MG/VIAL GENOTROPIN PRESERVATIVE FREE PHARMACIA AND UPJOHN 020280 SOMATROPIN RECOMBINANT Injection 5.8MG/VIAL GENOTROPIN PHARMACIA AND UPJOHN 020604 BX SOMATROPIN RECOMBINANT Injection 4MG/VIAL SEROSTIM SERONO 019764 BX SOMATROPIN RECOMBINANT Injection 5MG/VIAL SAIZEN SERONO 020604 BX SOMATROPIN RECOMBINANT Injection 5MG/VIAL SEROSTIM SERONO 019764 BX SOMATROPIN RECOMBINANT Injection 6MG/VIAL SAIZEN SERONO 020604 BX SOMATROPIN RECOMBINANT Injection 6MG/VIAL SEROSTIM SERONO 019764 SOMATROPIN RECOMBINANT Injection 8.8MG/VIAL SAIZEN SERONO 020604 SOMATROPIN RECOMBINANT Injection 8.8MG/VIAL SEROSTIM SERONO Zorbtive [Somatotropin (rDNA Origin)] Injection, Serono, Inc. Saizen (somatropin [rDNA origin] for injection), Serono, Inc., Package Change Serostim (somatropin [rDNA origin] for injection), Serono, Inc., Package Change Saizen (Somatropin) Injection, Serono, Inc., New or Modified Indication | Humatrope (somatropin [rDNA origin] Injection), Eli Lilly, Labeling Revision | Norditropin NordiFlex (somatropin [rDNA origin] injection), Novo Nordisk, Package Change | Norditropin Cartridges (somatropin rDNA origin) Injection, Novo Nordisk, New or Modified Indication | Saizen (somatropin [rDNA origin]) Injection, Serono, New or Modified Indication | Norditropin Cartridges (somatropin [rDNA origin]) injection, Novo Nordisk, New or Modified Indication | Saizen (somatropin [rDNA origin]) Injection, Serono, Inc., New or Modified Indication | Serostim LQ (somatropin [rDNA origin] injection), Serono, Formulation Revision | Tev-Tropin (somatropin) injection, Savient Pharma, Labeling Revision | Norditropin (somatropin [rDNA origin] injection), Novo Nordisk, Control Supplement

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