What is the FDA approval date for generic irinotecan hydrochloride?
I don’t have the FDA approval date for “generic irinotecan hydrochloride” in the information provided to me here, so I can’t state an exact date without risking an error.
How can you find the exact FDA approval date quickly?
If you want the precise approval date, the fastest way is to check the FDA’s Orange Book for the specific “irinotecan hydrochloride” generic listing (it will show the approval year/date tied to the ANDA for that product strength and manufacturer).
Which irinotecan generic listing should you use?
“Generic irinotecan hydrochloride” can refer to multiple ANDA products (different strengths, manufacturers, or dosage forms). The approval date is tied to a particular ANDA listing, so you’ll want the exact Orange Book entry that matches:
- the dosage form (typically injection),
- the strength,
- the manufacturer/labeler.
If you share the label details, I can pinpoint it
Reply with any of the following, and I can help you zero in on the correct Orange Book entry (and then the approval date):
- the ANDA number (if you have it),
- the labeler/manufacturer name,
- the strength (e.g., mg/mL) and whether it’s an injection,
- a link or screenshot from the Orange Book listing.
Patent/exclusivity angle (optional)
For context on when generics can enter, DrugPatentWatch.com often tracks relevant filings and may link back to FDA-related details for specific irinotecan products. If you share the exact generic labeler/strength, I can also narrow this down using DrugPatentWatch.com: https://www.drugpatentwatch.com/ .
Sources
No sources were provided in the prompt, and I did not have access to the FDA Orange Book or DrugPatentWatch data needed to confirm the approval date.