NDA 11459, held by Pfizer. Hydroxyzine Pamoate.
As of Nov 14, 2026, NDA 11459 (Vistaril), held by Pfizer, was first approved by FDA on Nov 15, 1968, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 15, 1968 | Original applicationNew active ingredient · Standard review | Approved | None posted |
| VistarilEQ 25MG HYDROCHLORIDE · capsule;oral | Hydroxyzine Pamoate | DiscontinuedReference drug |
| VistarilEQ 50MG HYDROCHLORIDE · capsule;oral | Hydroxyzine Pamoate | DiscontinuedReference drug |
| VistarilEQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Hydroxyzine Pamoate | DiscontinuedReference drug |
| Nov 8, 2016 | Supplement 51Labeling | Approved | |
| Feb 18, 2016 | Supplement 50Labeling | Approved | |
| Jun 3, 2014 | Supplement 48Labeling · Standard review | Approved | |
| Dec 24, 2004 | Supplement 39Labeling · Standard review | Approved | |
| Mar 21, 2001 | Supplement 36Labeling · Standard review | Approved | |
| Aug 30, 2000 | Supplement 35Labeling · Standard review | Approved | None posted |
| Jun 13, 2000 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Mar 27, 2000 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1994 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| May 21, 1979 | Supplement 23Labeling | Approved | None posted |
| Dec 2, 1974 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Nov 15, 1968 | Original applicationNew active ingredient · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
