CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | N020079 | EPIC PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Kirkpatrick & Lockhart LLP 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 | 505(q) | 2014-09-29 | Granted | Kirkpatrick & Lockhart LLP |
Citizen Petition from Sicor Pharmaceuticals, Inc. 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 | Other | 2008-07-29 | Open | Sicor Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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