FENTANYL CITRATE | N021947 | CEPHALON LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Cephalon Inc. et al v. Impax Laboratories Inc. 4 patentsANDA 203357fentanyl buccal tablets | D. Del. | 2011-11-18 | Terminated 2013-07-16 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Kramer & Amado, P.C. - Citizen Petition FDA-2010-P-0599 · 3 docket documents Law firm Kramer & Amado, P.C. filed this citizen petition on behalf of a client on November 17, 2010, requesting that the FDA determine that Cephalon, Inc.'s discontinuation of Fentora (fentanyl buccal tablet) 0.3 mg strength was not for safety or effectiveness reasons, thereby allowing generic alte | 505(q) | 2010-11-23 | Withdrawn | — |
Watson Laboratories, Inc. - Citizen Petition FDA-2010-P-0593 · 4 docket documents Watson Laboratories, Inc. submitted this citizen petition requesting that the FDA determine whether Cephalon's FENTORA (fentanyl buccal tablet) 300 mcg, approved under NDA 021947, was discontinued for reasons unrelated to safety and effectiveness, and if so, to declare ANDAs for this product eligibl | 505(q) | 2010-11-18 | Granted | — |
Cephalon, Inc. - Citizen Petition FDA-2010-P-0396 · 4 docket documents Cephalon, Inc. filed this citizen petition under 21 U.S.C. § 355 and 21 C.F.R. § 10.30 requesting that the FDA revise its draft bioequivalence guidance for fentanyl citrate buccal tablets and require sponsors of abbreviated new drug applications referencing FENTORA (fentanyl buccal tablet) to demons | 505(q) | 2010-08-02 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.