Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087871
Company: AUROLIFE PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 50MG TABLET;ORAL Discontinued None No No
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG TABLET;ORAL Discontinued None No No
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG 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
12/20/1982 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

06/03/2014 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

01/10/2000 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/21/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/14/1988 SUPPL-20 Labeling

Label is not available on this site.

04/25/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/25/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/08/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/08/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/21/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/21/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/21/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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