Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085779
Company: DR REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION 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
10/05/1979 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-96 Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-95 Labeling-Package Insert

Label is not available on this site.

06/03/2014 SUPPL-94 Labeling-Package Insert

Label is not available on this site.

02/19/1999 SUPPL-92 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-91 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/04/1996 SUPPL-90 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/23/1991 SUPPL-89 Labeling

Label is not available on this site.

02/11/1991 SUPPL-88 Labeling

Label is not available on this site.

11/21/1990 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

12/04/1989 SUPPL-86 Labeling

Label is not available on this site.

12/04/1989 SUPPL-85 Labeling

Label is not available on this site.

08/03/1989 SUPPL-84 Labeling

Label is not available on this site.

09/21/1988 SUPPL-82 Bioequivalence

Label is not available on this site.

08/03/1988 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

08/03/1988 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

05/28/1986 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

12/30/1983 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

02/08/1982 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

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