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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087329
Company: FRESENIUS KABI USA

Products on ANDA 087329

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087329

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.

Labels for ANDA 087329

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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