Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087604
Company: VINTAGE
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
01/22/1982 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-31 Labeling-Package Insert

Label is not available on this site.

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

Label is not available on this site.

06/03/2014 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

02/28/2013 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

08/03/1989 SUPPL-25 Labeling

Label is not available on this site.

06/20/1989 SUPPL-24 Labeling

Label is not available on this site.

10/15/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/15/1987 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/15/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/08/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/08/1983 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/08/1983 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/08/1983 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/10/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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