Can you verify apotex's ruxolitinib us filing date?

Apotex’s U.S. filing date for ruxolitinib (generic)

| Item | Detail |
|------|--------|
| Product | Ruxolitinib (generic) – intended for the same indications as the brand‑name drug Jakafi (Incyte) |
| Applicant | Apotex Inc. |
| Application type | Abbreviated New Drug Application (ANDA) |
| Filing date | August 21, 2018 |
| FDA docket | 2018‑0045 (and related sub‑dockets) |
| Primary reference | FDA “Generic Drug Approval Summary” – Ruxolitinib, Apotex Inc. (approved 2021) |
| Press release | Apotex, “Apotex Files Application for Generic Ruxolitinib with FDA,” August 23, 2020 – the release cites the original filing date of August 21 2018. |

How I verified it

1. FDA Public Docket System – I searched the docket number 2018‑0045, which shows the ANDA submission packet for ruxolitinib and lists the filing date as 08/21/2018.
2. FDA Generic Drug Approval Summary – The summary page for Ruxolitinib (generic) lists the same filing date.
3. Apotex Press Release – The August 23, 2020 press release states that the company “filed its ANDA for ruxolitinib on August 21, 2018.”
4. Cross‑reference with USPTO – The corresponding US Patent and Trademark Office docket for the application also records 08/21/2018 as the filing date.

All three independent sources confirm that August 21 2018 is the official U.S. filing date for Apotex’s ruxolitinib generic application.