Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087329
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION Discontinued None No No
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
08/11/1981 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-22 Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

09/25/2014 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087329Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087329Orig1s020ltr.pdf
06/04/2014 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087329Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087329Orig1s019ltr.pdf
12/05/2002 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

06/24/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/05/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/23/1993 SUPPL-9 Labeling

Label is not available on this site.

09/23/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/20/1990 SUPPL-7 Labeling

Label is not available on this site.

12/13/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/02/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/02/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/13/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/25/2014 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087329Orig1s020lbl.pdf
06/04/2014 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087329Orig1s019lbl.pdf

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