OTREXUP

FDA-2014-P-0318

Antares Pharma, Inc. filed this citizen petition under sections 505(b)(2) and 505(j)(2)(A)(vii) requesting that the FDA refrain from approving any drug application for subcutaneous methotrexate injection that does not reference Antares' NDA 204-824 for Otrexup™ as the reference listed drug and does

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