Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010392
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATARAX | HYDROXYZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ATARAX | HYDROXYZINE HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ATARAX | HYDROXYZINE HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ATARAX | HYDROXYZINE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/12/1956 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/21/2001 | SUPPL-41 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF |
| 03/27/2000 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/16/1998 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/12/1994 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/1998 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1985 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 05/21/1979 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 12/02/1974 | SUPPL-8 | Labeling |
Label is not available on this site. |