Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086880
Company: ANIMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP;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
07/17/1980 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-41 Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

06/03/2014 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

04/24/2003 SUPPL-33 Labeling

Label is not available on this site.

03/15/2000 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/15/2000 SUPPL-31 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/15/2000 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/2000 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/17/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/12/1995 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/11/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/17/1992 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/09/1990 SUPPL-22 Labeling

Label is not available on this site.

05/31/1989 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/31/1989 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/31/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/24/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/24/1987 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/09/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/02/1985 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/10/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/30/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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