Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088487
Company: BARR

Products on ANDA 088487

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088487

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/1984	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
02/16/2021	SUPPL-54	Labeling-Package Insert		Label is not available on this site.
02/16/2021	SUPPL-53	Labeling-Package Insert		Label is not available on this site.
01/24/2015	SUPPL-50	Labeling-Package Insert		Label is not available on this site.
10/09/2007	SUPPL-46	Labeling		Label is not available on this site.
01/03/2003	SUPPL-32	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
04/29/2002	SUPPL-31	Manufacturing (CMC)-Control		Label is not available on this site.
11/09/2001	SUPPL-30	Labeling		Label is not available on this site.
11/09/2001	SUPPL-29	Labeling		Label is not available on this site.
02/29/2000	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
12/21/1999	SUPPL-27	Manufacturing (CMC)-Facility		Label is not available on this site.
12/30/1999	SUPPL-26	Manufacturing (CMC)-Facility		Label is not available on this site.
05/20/1999	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
09/18/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
07/09/1998	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
09/20/1996	SUPPL-21	Labeling		Label is not available on this site.
04/10/1996	SUPPL-20	Labeling		Label is not available on this site.
12/23/1994	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
01/12/1995	SUPPL-14	Labeling		Label is not available on this site.
08/16/1991	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/16/1991	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/09/1991	SUPPL-11	Labeling		Label is not available on this site.
01/04/1990	SUPPL-10	Labeling		Label is not available on this site.
11/16/1987	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
11/16/1987	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/31/1987	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/25/1984	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088487

HYDROXYZINE PAMOATE

CAPSULE;ORAL; EQ 50MG HYDROCHLORIDE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	No	AB	088487	BARR
HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	No	AB	201507	HERITAGE PHARMA
HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	No	AB	040156	IMPAX LABS INC
HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	No	AB	086183	SANDOZ
VISTARIL	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	Yes	AB	011459	PFIZER