Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087760
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE;ORAL Discontinued None 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
03/05/1982 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
07/29/2002 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

11/13/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/2000 SUPPL-18 Labeling

Label is not available on this site.

01/28/2000 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

07/05/2000 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/30/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/30/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/30/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/16/1992 SUPPL-10 Labeling

Label is not available on this site.

10/26/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/01/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/11/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/15/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/15/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/15/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/25/1989 SUPPL-1 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English