FENTANYL CITRATE | N019101 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-2753 Law firm Hyman, Phelps & McNamara, P.C., on behalf of a client, filed a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Fentanyl Citrate Injection, USP, 50 mcg/mL in pharmacy bulk package presentations (100 mL, 500 mL, | Suitability | 2024-06-10 | Open | Hyman |
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 | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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