FENTANYL CITRATE | N020747 | CEPHALON LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services, Inc. FDA-2007-P-0062 · 7 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Oral Transmucosal Fentanyl Citrate in 1000 mcg and 1400 mcg strengths suitable for submission as an ANDA, with Actiq (oral | Other | 2008-07-10 | Granted | Lachman Consultant Services, Inc. |
Citizen Petition from Mylan Laboratories Inc. FDA-2006-P-0016 · 10 docket documents 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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