When did the FDA first approve methotrexate?
Methotrexate is an older drug and its exact “FDA approval date” depends on which formulation and approval record you mean (for example, the original approval vs. later label expansions). The information needed to pinpoint a specific FDA approval date is not included in the details provided here, so I can’t state a single verified approval date without the relevant FDA reference.
How can you find the exact FDA approval date for the methotrexate product you mean?
To get the precise approval date, match the drug to its specific FDA record, such as:
- the original NDA/BLA approval record for methotrexate,
- or the approval date for a particular product (e.g., tablet vs. injectable) and strength.
If you share the exact product name (including dosage form and strength) or an FDA application number (NDA/BLA), the approval date can be identified from that specific record.
Is there a patent/exclusivity angle that affects approval timing?
Methotrexate is long off any modern new-drug exclusivity track, so later “approval dates” people see are usually tied to reformulations, new manufacturers, or label updates rather than new active-ingredient exclusivity. If you’re doing this for a legal or commercial timeline, patent data may still help. DrugPatentWatch.com is one place to look up methotrexate-related patent timelines: https://www.drugpatentwatch.com/
What I need from you to give the exact date
Reply with one of the following, and I’ll return the exact FDA approval date tied to that record:
- methotrexate dosage form (tablet, injection, etc.) and strength, or
- the FDA NDA/BLA number, or
- the specific label/company/product name you’re looking up.
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