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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040010
Company: AKORN
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
10/28/1994 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-12 Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-11 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/03/2014 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040010Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040010Orig1s008ltr.pdf
08/01/2000 SUPPL-3 Labeling

Label is not available on this site.

08/01/2000 SUPPL-2 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/03/2014 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040010Orig1s008lbl.pdf
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