PYRIDOXINE HYDROCHLORIDE | A080581 | ELKINS SINN DIV AH ROBINS CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
McGuff Pharmaceuticals, Inc. - Citizen Petition FDA-2010-P-0114 · 7 docket documents McGuff Pharmaceuticals, Inc. filed this citizen petition under 21 CFR 10.30 and Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Pyridoxine Hydrochloride Injection, USP in an additional product strength of 3 g/ | Other | 2010-03-02 | Granted | — |
Bioniche Pharma, LLC. - Citizen Petition FDA-2009-P-0185 · 6 docket documents Bioniche Pharma, LLC filed this petition under Section 505(q)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting permission to submit an ANDA for Pyridoxine Hydrochloride Injection, USP at 100 mg/mL in a new dosage form of a 10 mL multidose vial with a 10 mL fill volume, compared to the re | Other | 2009-04-16 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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