Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 085929
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
A-HYDROCORT HYDROCORTISONE SODIUM SUCCINATE EQ 100MG BASE/VIAL 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
03/28/1978 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
10/22/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/28/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/31/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/28/1994 SUPPL-15 Labeling

Label is not available on this site.

12/27/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/11/1990 SUPPL-13 Labeling

Label is not available on this site.

12/26/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/04/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/15/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/10/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/10/1982 SUPPL-3 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