PREDNISOLONE | N009996 | PFIZER LABORATORIES DIV PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Muro Pharmaceutical, INC. FDA-1983-P-0373 · 2 docket documents Muro Pharmaceutical, Inc. filed this citizen petition on December 6, 1983, requesting that the FDA determine the suitability of a Prednisolone Syrup formulation containing 5 mg per 1.7 ml for submission as an Abbreviated New Drug Application by establishing it as similar and related to the previousl | 505(q) | 2025-01-06 | Granted | Muro Pharmaceutical, INC. |
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of 10mg prednisolone base/5mL, which would be an intermediate strength between the curren | Other | 2024-07-02 | Withdrawn | Olsson, Frank and Weeda, P.C. |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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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