Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088350
Company: WATSON LABS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/15/1983 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-47 Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

12/31/2014 SUPPL-45 Labeling-Package Insert

Label is not available on this site.

11/26/2001 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/2002 SUPPL-23 Labeling

Label is not available on this site.

03/23/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/29/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/19/1990 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/30/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/30/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/14/1989 SUPPL-11 Labeling

Label is not available on this site.

11/21/1988 SUPPL-10 Labeling

Label is not available on this site.

01/30/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/30/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/12/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/15/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/15/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/20/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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