OTREXUP

FDA-1997-P-0357 · 8 docket documents

Gensia Laboratories, Ltd. filed an ANDA suitability petition for leucovorin calcium for injection. The petition seeks FDA confirmation that an abbreviated new drug application can be submitted for a generic version of this drug, which is indicated for rescue after high-dose methotrexate therapy and

FDA-2018-P-0033 · 3 docket documents

The law firm Hyman, Phelps & McNamara filed this citizen petition pursuant to Section 505(j) of the Federal Food, Drug and Cosmetic Act requesting that FDA designate RASUVO (methotrexate) Injection, approved under NDA 205776, as a Reference Listed Drug in the Orange Book to enable the submission of

FDA-2002-P-0218 · 5 docket documents

Kirkpatrick & Lockhart LLP filed this citizen petition on behalf of a pharmaceutical client on May 17, 2002, requesting FDA authorization pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act to submit an abbreviated new drug application for methotrexate sodium oral solution a

FDA-2014-P-0318 · 3 docket documents

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 · 7 docket documents

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-0131 · 8 docket documents

SICOR Pharmaceuticals, Inc. filed this citizen petition on December 15, 2006, requesting that the FDA determine whether Methotrexate Injection, USP, Preservative Free, 500 mg base/20 mL (NDA No. 11-719, held by Mayne Pharma USA) was voluntarily withdrawn for safety or efficacy reasons, and to confir

FDA-2006-P-0401 · 6 docket documents

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