Drugs@FDA: FDA-Approved Drugs

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

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

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