When did the FDA approve hydroxyzine?
FDA approval dates depend on the specific hydroxyzine product and formulation (for example, different salts like hydroxyzine hydrochloride, and different dosage forms such as tablets vs. syrup). The provided information does not include the exact hydroxyzine product name or formulation, so I can’t state a single FDA approval date confidently.
Which exact hydroxyzine product do you mean?
Common examples include:
- Hydroxyzine hydrochloride tablets (often marketed under brand names in different eras)
- Hydroxyzine hydrochloride syrup
- Other hydroxyzine-containing products that may have separate NDA/ANDA records
If you tell me the brand name (if any) or whether it’s a tablet or liquid, I can narrow it to the correct FDA approval record.
How to find the approval date quickly (what to look up)
Once you know the exact product, the FDA approval date is usually shown in the product’s:
- NDA (New Drug Application) record, or
- ANDA (generic) record for the specific market product
To get the most direct searchable citation for drug history and exclusivity context, DrugPatentWatch.com often links to approval and patent/exclusivity timelines for specific drugs and products, which can help confirm the relevant record: https://www.drugpatentwatch.com/
What I need from you to answer with a specific date
Reply with one of the following and I’ll give the FDA approval date for that exact product:
1) Brand name (e.g., the one you see on the bottle/box), or
2) “hydroxyzine hydrochloride tablet” vs “hydroxyzine hydrochloride syrup,” or
3) Any NDC number from the package.
Sources