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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011459
Company: PFIZER

Products on NDA 011459

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VISTARIL	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	AB	Yes	No
VISTARIL	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE;ORAL	Prescription	AB	Yes	No
VISTARIL	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011459

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/15/1968	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD		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-51	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s051_011795s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011459Orig1s051,011795Orig1s028ltr.pdf
02/18/2016	SUPPL-50	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s050,011795s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011459Orig1s050,011795Orig1s027ltr.pdf
06/03/2014	SUPPL-48	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011459s048,011795s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011459Orig1s048,011795Orig1s025ltr.pdf
12/24/2004	SUPPL-39	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11459s039,11795s020ltr.pdf
06/13/2000	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
03/27/2000	SUPPL-37	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/21/2001	SUPPL-36	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF
08/30/2000	SUPPL-35	Labeling		Label is not available on this site.
11/28/1994	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
05/21/1979	SUPPL-23	Labeling		Label is not available on this site.
12/02/1974	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 011459

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/2016	SUPPL-51	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s051_011795s028lbl.pdf
02/18/2016	SUPPL-50	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s050,011795s027lbl.pdf
06/03/2014	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011459s048,011795s025lbl.pdf

Therapeutic Equivalents for NDA 011459

VISTARIL

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

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

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