ROPIVACAINE HYDROCHLORIDE | N020533 | FRESENIUS KABI USA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Fresenius Kabi USA, LLC et al v. Baxter Healthcare Corporation et al 4 patentsANDA 215691ropivacaine hydrochloride | D. Del. | 2021-07-16 | Terminated 2022-05-05 | — |
FRESENIUS KABI USA LLC, et al. WOCKHARDT USA LLC, et al. 1 patentANDA 206320ropivacaine hydrochloride | D.N.J. | 2019-11-15 | Terminated 2020-02-05 | — |
Fresenius Kabi USA, LLC et al v. Custopharm, Inc. 3 patentsANDA 211907ropivacaine hydrochloride | TXWD | 2018-08-06 | Terminated 2019-08-13 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-2758 Hyman, Phelps & McNamara, P.C., on behalf of a client and at the directive of the Office of Generic Drugs, filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that FDA declare Ropivacaine Hydrochloride Injection, US | Suitability | 2024-06-10 | Open | Hyman |
Suitability Petition Approval Letter from FDA CDER to McGuire Woods LLP FDA-2013-P-1203 McGuire Woods LLP filed a petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting approval to submit an ANDA for Ropivacaine Hydrochloride Injection at 2 mg/mL in a 500 mL infusion bag, which differs in container size from the listed drug NAROPIN at 2 mg/mL in a 20 | Suitability | 2016-09-23 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.