FDA Orange Book · active-ingredient family
Hydroxyzine pamoate
Hydroxyzine pamoate is approved as 2 brand and 35 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VISTARIL · NDA 011459
2
Brand (NDA)
35
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VISTARILRLD×3 | PFIZER | NDA 011459 | AB | Approved Prior to Jan 1, 1982 | |
| VISTARILRLD | PFIZER | NDA 011795 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (35)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROXYZINE PAMOATE×2 | HERITAGE PHARMA | ANDA 201507 | AB | Jun 03, 2013 | |
| HYDROXYZINE PAMOATE×2 | IMPAX LABS INC | ANDA 040156 | AB | Jul 15, 1996 | |
| HYDROXYZINE PAMOATE | WATSON LABS | ANDA 081165 | — | Jul 31, 1991 | |
| HYDROXYZINE PAMOATE | BEXIMCO PHARMS USA | ANDA 081127 | — | Jun 28, 1991 | |
| HYDROXYZINE PAMOATE | SANDOZ | ANDA 081128 | — | Jun 28, 1991 | |
| HYDROXYZINE PAMOATE | SANDOZ | ANDA 081129 | — | Jun 28, 1991 | |
| HYDROXYZINE PAMOATE | SUPERPHARM | ANDA 089031 | — | Jan 02, 1987 | |
| HYDROXYZINE PAMOATE | SUPERPHARM | ANDA 089032 | — | Jan 02, 1987 | |
| HYDROXYZINE PAMOATE | SUPERPHARM | ANDA 089033 | — | Jan 02, 1987 | |
| HYDROXYZINE PAMOATE | PAR PHARM | ANDA 089145 | — | Mar 17, 1986 | |
| HYDROXYZINE PAMOATE | PAR PHARM | ANDA 089146 | — | Mar 17, 1986 | |
| "HY-PAM ""25""" | TEVA | ANDA 088713 | — | Mar 04, 1985 | |
| HYDROXYZINE PAMOATE | BARR | ANDA 088496 | AB | Jun 15, 1984 | |
| HYDROXYZINE PAMOATE | BARR LABS | ANDA 088487 | AB | Jun 15, 1984 | |
| HYDROXYZINE PAMOATE | BARR LABS | ANDA 088488 | — | Jun 15, 1984 | |
| HYDROXYZINE PAMOATE | DURAMED PHARMS BARR | ANDA 088593 | — | Feb 29, 1984 | |
| HYDROXYZINE PAMOATE | DURAMED PHARMS BARR | ANDA 088594 | — | Feb 29, 1984 | |
| HYDROXYZINE PAMOATE | DURAMED PHARMS BARR | ANDA 088595 | — | Feb 29, 1984 | |
| HYDROXYZINE PAMOATE | VANGARD | ANDA 088392 | — | Sep 19, 1983 | |
| HYDROXYZINE PAMOATE | VANGARD | ANDA 088393 | — | Sep 19, 1983 | |
| HYDROXYZINE PAMOATE | WATSON LABS | ANDA 086728 | — | Oct 05, 1982 | |
| HYDROXYZINE PAMOATE | WATSON LABS | ANDA 087767 | — | Aug 16, 1982 | |
| HYDROXYZINE PAMOATE | WATSON LABS | ANDA 087790 | — | Aug 16, 1982 | |
| HYDROXYZINE PAMOATE | WATSON LABS | ANDA 086840 | — | Jul 01, 1982 | |
| HYDROXYZINE PAMOATE | WATSON LABS | ANDA 086705 | — | Jul 01, 1982 | |
| HYDROXYZINE PAMOATE | PAR PHARM | ANDA 087656 | — | Jun 11, 1982 | |
| HYDROXYZINE PAMOATE | PAR PHARM | ANDA 087657 | — | Jun 11, 1982 | |
| HYDROXYZINE PAMOATE | PAR PHARM | ANDA 087658 | — | Jun 11, 1982 | |
| HYDROXYZINE PAMOATE | IVAX SUB TEVA PHARMS | ANDA 087761 | — | Mar 05, 1982 | |
| HYDROXYZINE PAMOATE | IVAX SUB TEVA PHARMS | ANDA 087760 | — | Mar 05, 1982 | |
| HYDROXYZINE PAMOATE | SANDOZ | ANDA 087479 | AB | Approved Prior to Jan 1, 1982 | |
| HYDROXYZINE PAMOATE | SANDOZ | ANDA 086183 | AB | Approved Prior to Jan 1, 1982 | |
| HYDROXYZINE PAMOATE | WATSON LABS | ANDA 086698 | — | Approved Prior to Jan 1, 1982 | |
| HYDROXYZINE PAMOATE | WATSON LABS | ANDA 086695 | — | Approved Prior to Jan 1, 1982 | |
| HYDROXYZINE PAMOATE | WATSON LABS | ANDA 086697 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Hydroxyzine pamoate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
