NALOXONE HYDROCHLORIDE | N208411 | EMERGENT OPERATIONS IRELAND LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ADAPT PHARMA OPERATIONS LIMITED et al v. PERRIGO UK FINCO LIMITED PARTNERSHIP 1 patentANDA 211951naloxone hydrochloride | D.N.J. | 2018-12-07 | Terminated 2019-05-03 | — |
ADAPT PHARMA OPERATIONS LIMITED et al v. TEVA PHARMACEUTICALS USA, INC. et al 2 patentsANDA 211561naloxone hydrochloride | D.N.J. | 2018-04-09 | Terminated 2022-07-27 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-0514 Hyman, Phelps & McNamara, P.C. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Naloxone HCl Nasal Spray, 8 mg/Spray, suitable for submission as an ANDA, with NARCAN Nasal Spray (NDA 208411) as the reference listed dru | Suitability | 2021-05-27 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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