FENTANYL CITRATE | N016619 | RISING PHARMA HOLDINGS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Olsson Frank Weeda Terman Bode Matz PC - Citizen Petition FDA-2010-P-0413 · 6 docket documents The law firm Olsson Frank Weeda Terman Bode Matz PC filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine a new strength of Fentanyl Citrate Injection, USP at 50 mcg (50 mcg/1mL) is suitable for submission as an abbreviat | Other | 2010-08-10 | 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 | — |
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. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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