FENTANYL CITRATE | N019101 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-2753 · 8 docket documents 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 | Granted | Hyman, Phelps & McNamara, P.C. |
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 | — |
Patrick Foster - Citizen Petition FDA-2010-P-0222 · 3 docket documents Patrick Foster filed this citizen petition in April 2010 under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting FDA approval to submit an Abbreviated New Drug Application for Fentanyl Citrate Injection Solution at a concentration of 50 mcg/mL in a larger 500 mL single-dos | Other | 2010-04-29 | Withdrawn | — |
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.
Highest NADAC/Unit
$1.42
per ml
Lowest NADAC/Unit
$1.42
per ml
Brand NDCs
0
Generic NDCs
7
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00641602725FENTANYL 100 MCG/2 ML VIAL | $1.42 | ML | Generic | — | 2026-06-17 |
| 72572017025FENTANYL 100 MCG/2 ML VIAL | $1.42 | ML | Generic | — | 2026-06-17 |
| 72572017110FENTANYL 250 MCG/5 ML VIAL | $1.42 | ML | Generic | — | 2026-06-17 |
| 72572017201FENTANYL 2,500 MCG/50 ML VIAL | $1.42 | ML | Generic | — | 2026-06-17 |
| 00641602810FENTANYL 250 MCG/5 ML VIAL | $1.42 | ML | Generic | — | 2026-06-17 |
| 00641603001FENTANYL 2,500 MCG/50 ML VIAL | $1.42 | ML | Generic | — | 2026-06-17 |
| 81565020502FENTANYL 100 MCG/2 ML VIAL | $1.42 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.