Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010392
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ATARAX HYDROXYZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
ATARAX HYDROXYZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
ATARAX HYDROXYZINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
ATARAX HYDROXYZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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.

05/21/1979 SUPPL-21 Labeling

Label is not available on this site.

12/02/1974 SUPPL-8 Labeling

Label is not available on this site.

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