Composition
- Active ingredients
- HYDROXYZINE HYDROCHLORIDE 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- HYDROXYZINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA010392-005 · Discontinued
- HYDROXYZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA010392-001 · Discontinued
- HYDROXYZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA010392-006 · Discontinued
- HYDROXYZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA010392-004 · Discontinued
- HYDROXYZINE HYDROCHLORIDE 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SyrupThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA010485.
At a glance
- Brand name
- Atarax
- Active substance
- hydroxyzine hydrochloride
- Route
- Oral
- Dosage form
- Syrup
- Applicant
- Roerig
- Status
- Discontinued
- FDA approval
- 31 May 1956
- Application
- NDA010485-001