Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040010
Company: HIKMA

Products on ANDA 040010

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040010

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.

Labels for ANDA 040010

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