PREDNISONE | N010962 | PARKE DAVIS DIV WARNER LAMBERT CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Horizon Pharma, Inc. - Citizen Petition FDA-2013-P-1283 · 3 docket documents Horizon Pharma, Inc. filed this citizen petition on October 4, 2013, requesting that FDA require any ANDA referencing RAYOS (prednisone) delayed-release tablets 1 mg, 2 mg, or 5 mg as the reference listed drug establish bioequivalence by demonstrating that the generic product has an equivalent lag t | 505(q) | 2013-11-14 | Partially Denied | — |
Public Citizen Health Research Group - Citizen Petition FDA-2011-P-0604 · 6 docket documents Public Citizen's Health Research Group filed this petition on July 26, 2011, requesting that the FDA immediately revise product labels for all brands of prednisone and other glucocorticosteroids currently marketed in the United States to include central serous chorioretinopathy as an ophthalmic adve | Other | 2011-09-01 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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