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I don’t have real-time access to the FDA Orange Book right now to pull the exact filing date. The precise US filing date for Apotex’s ruxolitinib ANDA is listed in the FDA’s Orange Book under the sponsor “Apotex Corp” for the ruxolitinib product (and it may be listed separately for different strengths/formulations). How to find it quickly: - Go to the FDA Orange Book search page: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm - Search for “ruxolitinib” and filter by sponsor “Apotex Corp” (or “APOTEX”). - Open the relevant ANDA entry(s). Look for the “Date Filed” field (this is the exact filing date). There may be multiple entries if Apotex has multiple dosage forms or strengths. If you’d like, you can share the Orange Book entry or the ANDA number here, and I’ll help confirm the exact filing date and interpret any related notes (e.g., approval status, patent certifications).
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