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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087479
Company: SANDOZ

Products on ANDA 087479

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087479

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/1981	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
02/16/2021	SUPPL-41	Labeling-Package Insert		Label is not available on this site.
02/16/2021	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
01/24/2015	SUPPL-39	Labeling-Package Insert		Label is not available on this site.
06/27/2013	SUPPL-31	Labeling-Container/Carton Labels		Label is not available on this site.
12/20/2002	SUPPL-23	Labeling		Label is not available on this site.
02/02/2000	SUPPL-22	Manufacturing (CMC)-Facility		Label is not available on this site.
06/24/1996	SUPPL-21	Labeling		Label is not available on this site.
04/12/1996	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
05/22/1996	SUPPL-19	Labeling		Label is not available on this site.
12/09/1994	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/03/1995	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
03/03/1995	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/12/1992	SUPPL-15	Labeling		Label is not available on this site.
12/12/1994	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/09/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
12/12/1994	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/09/1989	SUPPL-10	Labeling		Label is not available on this site.
03/07/1986	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/07/1986	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 087479

HYDROXYZINE PAMOATE

CAPSULE;ORAL; EQ 25MG 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 25MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	No	AB	088496	BARR
HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	No	AB	201507	HERITAGE PHARMA
HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	No	AB	040156	IMPAX LABS INC
HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	No	AB	087479	SANDOZ
VISTARIL	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	Yes	AB	011459	PFIZER

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