Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086183
Company: SANDOZ
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
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
01/24/2015 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

07/22/2013 SUPPL-32 Labeling-Container/Carton Labels

Label is not available on this site.

12/20/2002 SUPPL-24 Labeling

Label is not available on this site.

02/02/2000 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

06/24/1996 SUPPL-22 Labeling

Label is not available on this site.

04/12/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/22/1996 SUPPL-20 Labeling

Label is not available on this site.

12/09/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/03/1995 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.

07/28/1992 SUPPL-16 Labeling

Label is not available on this site.

12/12/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/09/1994 SUPPL-14 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-11 Labeling

Label is not available on this site.

01/17/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/09/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/09/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/09/1982 SUPPL-1 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
VISTARIL HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE;ORAL Prescription Yes AB 011459 PFIZER

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