Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087408
Company: AM REGENT

Products on ANDA 087408

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087408

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/27/1981	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-26	Labeling-Package Insert		Label is not available on this site.
03/30/2016	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
06/03/2014	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
01/02/2003	SUPPL-15	Labeling		Label is not available on this site.
07/17/2002	SUPPL-14	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
09/25/1997	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
02/28/1996	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/24/1992	SUPPL-11	Labeling		Label is not available on this site.
04/02/1992	SUPPL-10	Labeling		Label is not available on this site.
09/04/1991	SUPPL-9	Labeling		Label is not available on this site.
05/22/1991	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/13/1991	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.