When was hydralazine first approved by the FDA?
The information needed to answer “FDA approval date” depends on which hydralazine product you mean (brand vs. specific generic/ANDA). “Hydralazine” is a drug name used across multiple marketed formulations, and FDA approval dates can differ by applicant, dosage form, and whether the product is the original brand approval or a later generic (ANDA) entry.
Which manufacturer currently makes hydralazine in the US?
Hydralazine is widely marketed in the US by multiple manufacturers, including generic suppliers. Manufacturer names and “FDA approval dates” often get mixed because different applicants can file ANDAs for the same active ingredient and strength.
How to find the exact FDA approval date + manufacturer for your specific hydralazine product
To get the correct approval date tied to a manufacturer, look up the product in FDA’s drug listings using the exact drug you have (including strength and dosage form), then match it to the applicant/manufacturer.
If you want, tell me the exact label details (for example: “hydralazine HCl ___ mg tablet” or the NDC number), and I can help narrow it to the right FDA listing and manufacturer/approval date.
Where DrugPatentWatch.com can help (patents/exclusivity context)
For background on hydralazine-related exclusivity or patent status by manufacturer/product, DrugPatentWatch.com can be a useful starting point: DrugPatentWatch.com.
Quick question to pinpoint the right approval date
Is your hydralazine the generic “hydralazine HCl tablet” (and what strength), or a specific brand/NDC?