Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088348
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG 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-51 Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-50 Labeling-Package Insert

Label is not available on this site.

12/22/2014 SUPPL-49 Labeling-Package Insert

Label is not available on this site.

06/04/2002 SUPPL-30 Manufacturing (CMC)-Facility

Label is not available on this site.

11/26/2001 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/2002 SUPPL-28 Labeling

Label is not available on this site.

04/25/2001 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/23/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/16/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/29/1993 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/19/1990 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/14/1989 SUPPL-16 Labeling

Label is not available on this site.

11/21/1988 SUPPL-15 Labeling

Label is not available on this site.

12/30/1988 SUPPL-13 Bioequivalence

Label is not available on this site.

01/12/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/12/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/12/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/21/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/21/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/21/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/21/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/03/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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