PREDNISONE | N010962 | PARKE DAVIS DIV WARNER LAMBERT CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Horizon Pharma, Inc. - Citizen Petition FDA-2013-P-1283 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 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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