FENTANYL | N019813 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 1 - "ANDA Suitability Petition for Fentanyl Citrate Injection USP"... FDA-2010-P-0413 Olsson Frank Weeda Terman Bode Matz PC filed a citizen petition requesting that the FDA determine fentanyl citrate injection USP is suitable for abbreviated new drug application approval, enabling generic manufacturers to pursue ANDA pathways for this injectable fentanyl product. | Suitability | 2010-08-10 | Open | — |
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.
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