RASUVO

FDA-2006-P-0077

Sicor Pharmaceuticals, Inc. filed an ANDA suitability petition regarding Methotrexate Injection, USP, requesting approval for marketing an isotonic preservative formulation (25 mg/mL in 2 mL vials containing 50 mg methotrexate with benzyl alcohol as preservative) and a preservative-free formulation

FDA-2006-P-0077

Sicor Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, submitted an ANDA suitability petition under Section 505(j)(2)(c) requesting permission to file an abbreviated new drug application for Methotrexate Injection, USP at a strength of 1,000 mg in 10 mL (100 mg/mL) in a single-use vi

FDA-2006-P-0077

Sicor Pharmaceuticals, Inc. filed an ANDA suitability petition requesting approval for Methotrexate Injection, USP, Preservative Free in various strengths (10 mg/mL in 2 mL vials and 25 mg/mL in 20 mL, 40 mL, and 100 mL vials) manufactured by Mayne Pharma USA, which is used for treating neoplastic d

FDA-2006-P-0077

Sicor Pharmaceuticals, Inc. filed this suitability petition requesting FDA approval to submit an Abbreviated New Drug Application (ANDA) for Methotrexate Injection, USP in a 1,000 mg/10 mL (100 mg/mL) concentration. The petitioner argues that this higher-concentration liquid formulation, which is pr

FDA-2006-P-0401

Sicor Pharmaceuticals, Inc. filed an ANDA Suitability Petition under Section 505(j)(2)(c) requesting permission to submit an abbreviated new drug application for Methotrexate Injection, USP at a concentration of 100 mg/mL in a ready-to-use liquid formulation (1,000 mg/10 mL single-use vial), which d