Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081150
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
03/18/1994 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-13 Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

06/04/2014 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/12/2001 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

09/25/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/08/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/26/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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