Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087760
Company: IVAX SUB TEVA PHARMS

Products on ANDA 087760

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087760

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/05/1982	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
07/29/2002	SUPPL-21	Manufacturing (CMC)-Facility		Label is not available on this site.
09/12/2001	SUPPL-20	Manufacturing (CMC)-Facility		Label is not available on this site.
11/13/2000	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
07/05/2000	SUPPL-18	Labeling		Label is not available on this site.
01/28/2000	SUPPL-17	Manufacturing (CMC)-Facility		Label is not available on this site.
07/05/2000	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/30/1999	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/30/1999	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/30/1999	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
12/09/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/30/1997	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
10/16/1992	SUPPL-10	Labeling		Label is not available on this site.
10/26/1992	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/01/1992	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/11/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/15/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/15/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/15/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/25/1989	SUPPL-1	Labeling		Label is not available on this site.