Details for New Drug Application (NDA): 010392
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NDA 010392 describes ATARAX, which is a drug marketed by Roerig and Pfizer and is included in two NDAs. Additional details are available on the ATARAX profile page.
The generic ingredient in ATARAX is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
The generic ingredient in ATARAX is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 010392
| Tradename: | ATARAX |
| Applicant: | Pfizer |
| Ingredient: | hydroxyzine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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