PREDNISOLONE SODIUM PHOSPHATE | N011028 | MERCK AND CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Olsson, Frank and Weeda, P.C. FDA-2006-P-0285 · 5 docket documents Law firm Olsson, Frank and Weeda, P.C. filed this citizen petition under Section 505(j)(2)(C) of the FDC Act requesting permission to submit an ANDA for prednisolone sodium phosphate oral solution at a strength of 10mg prednisolone base/5mL, which would be an intermediate strength between the curren | Other | 2024-07-02 | Withdrawn | Olsson, Frank and Weeda, P.C. |
Citizens petition from FISONS CORP FDA-1987-P-0039 · 2 docket documents Fisons Corporation filed this citizen petition on July 1, 1987, requesting that the FDA issue a determination of suitability for submitting an abbreviated new drug application for a prednisolone sodium phosphate oral solution containing 15 mg prednisolone base per 5 mL, under 21 CFR 314.55(b)(c)(d). | Other | 2021-02-08 | Granted | FISONS CORP |
Citizen Petition from We Pharmaceuticals, Inc. FDA-1996-P-0316 · 2 docket documents We Pharmaceuticals, Inc. filed a suitability petition on December 13, 1996, requesting the FDA to determine that a 20.1mg Prednisolone Sodium Phosphate USP oral liquid formulation (15mg prednisolone base per 5ml) is suitable for an Abbreviated New Drug Application, as being similar and related to th | Other | 2017-05-04 | Open | We Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.