FENTANYL CITRATE | N020747 | CEPHALON LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Mylan Laboratories Inc. FDA-2006-P-0016 Mylan Laboratories Inc. filed this citizen petition on July 21, 2006, requesting that the FDA determine whether a Risk Management Program is necessary for transdermal fentanyl drug products and, if so, that the FDA develop and adopt a single, unified Risk Management Program for all transdermal fenta | Other | 2008-06-23 | Partially Denied | Mylan Laboratories Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.