Which methotrexate product has an “elite pharmaceuticals” connection, and what is its approval date?
The information provided in the question is too incomplete to identify a specific methotrexate drug/strength or the exact “Elite Pharmaceuticals” submission you mean. Approval dates depend on the exact product label (for example, tablets vs. injection), strength, and whether it is an ANDA (generic) or another type of application.
If you share either:
- the exact product name (including strength and dosage form), or
- the National Drug Code (NDC), or
- a link/name of the specific label you’re looking at,
I can give you the corresponding approval date for that exact methotrexate product.
How to find methotrexate approval dates (ANDA) for a specific company
For generic drugs, the approval date is tied to the specific ANDA submission for that product (strength + dosage form). The fastest way to match “Elite Pharmaceuticals” to the right approval date is to search by:
- company name + methotrexate, then
- select the matching dosage form/strength entry, and
- read the “Approval Date” shown for that exact item.
A common reference for this is DrugPatentWatch.com, which tracks drug approvals and related patent/exclusivity details. You can start here: DrugPatentWatch.com.
Is “Elite Pharmaceuticals” the manufacturer, the label holder, or the applicant?
People sometimes use “Elite Pharmaceuticals” to refer to different roles:
- the applicant/ANDA holder (who is seeking approval),
- the manufacturer (who produces the product),
- or the labeled marketing authorization holder.
Approval dates generally follow the regulatory application (ANDA) rather than the physical manufacturer alone. That’s why the exact product identification matters.
What I need from you to answer with a precise approval date
Reply with one of the following and I’ll pin down the approval date:
1) Methotrexate dosage form and strength (example: methotrexate tablets 2.5 mg; methotrexate injection 50 mg/ mL)
2) The NDC for the product
3) The exact product name as written on the label or in the listing you’re using
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