ABIRATERONE ACETATE | N210308 | SUN PHARMACEUTICAL INDUSTRIES LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Sun Pharma Global FZE et al v. Teva Pharmaceuticals USA, Inc. 1 patentANDA 212206Abiraterone Acetate | D. Del. | 2018-10-09 | Terminated 2020-05-07 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from MSN Laboratories Private Limited FDA-2025-P-2547 · 10 docket documents MSN Laboratories Private Limited filed this amendment to Docket ID FDA-2025-P-2547 in response to an FDA information request regarding a suitability petition for Abiraterone Acetate Tablets 1000 mg, submitting proposed product labeling for the drug indicated for treating metastatic castration-resist | Suitability | 2025-08-11 | Granted | MSN Laboratories Private Limited |
Citizen Petition from Anne A. Shirinian-Orlando FDA-2018-P-2749 · 4 docket documents Anne A. Shirinian-Orlando filed this petition under Section 355(e) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA issue strict dosage and administration guidelines for prostate cancer chemotherapy medications including Zytiga (abiraterone acetate), Jevtana (cabazitaxel), and Xta | Other | 2018-07-18 | Open | Anne A. Shirinian-Orlando |
Source: Regulations.gov. FDA citizen petitions matched by application number.