Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087603
Company: STRIDES PHARMA

Products on ANDA 087603

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087603

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/22/1982	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-31	Labeling-Package Insert		Label is not available on this site.
03/30/2016	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
06/03/2014	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
02/28/2013	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
08/06/1989	SUPPL-25	Labeling		Label is not available on this site.
06/20/1989	SUPPL-24	Labeling		Label is not available on this site.
10/15/1987	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
10/15/1987	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
10/15/1987	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
11/08/1983	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
11/08/1983	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/08/1983	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
11/08/1983	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/10/1982	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.