FULVESTRANT | N210063 | AVYXA HOLDINGS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ASTRAZENECA PHARMACEUTICALS LP et al v. TEVA PHARMACEUTICALS USA, INC. 4 patentsfulvestrant | D.N.J. | 2017-04-10 | Terminated 2018-01-29 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Teva Pharmaceuticals USA, Inc. FDA-2019-P-3937 Teva Pharmaceuticals USA, Inc. filed this citizen petition requesting that the FDA assign a therapeutic equivalence code of "AO" to Teva's Fulvestrant Injection, 250 mg/5 ml (50 mg/ml), which was approved under NDA 210063 on August 19, 2019 pursuant to Section 505(b)(2) of the Federal Food, Drug and | Other | 2019-08-21 | Denied | Teva Pharmaceuticals USA |
Citizen Petition from AstraZeneca Pharmaceuticals LP FDA-2017-P-3092 AstraZeneca Pharmaceuticals LP filed this petition under section 505 of the FDCA requesting that the FDA refrain from approving Teva Pharmaceuticals USA, Inc.'s section 505(b)(2) new drug application for fulvestrant injection, 50 mg/mL, which cites AstraZeneca's Faslodex IM injection as the listed d | 505(q) | 2017-05-16 | Denied | AstraZeneca Pharmaceuticals LP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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