Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 085778
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION 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
10/05/1979 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
11/08/2016 SUPPL-54 Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-53 Labeling-Package Insert

Label is not available on this site.

06/03/2014 SUPPL-52 Labeling-Package Insert

Label is not available on this site.

02/19/1999 SUPPL-50 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-49 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/04/1996 SUPPL-48 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/23/1991 SUPPL-47 Labeling

Label is not available on this site.

01/25/1991 SUPPL-46 Labeling

Label is not available on this site.

12/04/1989 SUPPL-45 Labeling

Label is not available on this site.

12/04/1989 SUPPL-44 Labeling

Label is not available on this site.

11/15/1988 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/30/1988 SUPPL-37 Bioequivalence

Label is not available on this site.

10/02/1986 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

12/30/1983 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/15/1982 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/15/1982 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/15/1982 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/15/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/15/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/15/1982 SUPPL-1 Manufacturing (CMC)

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