Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071583
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE;INJECTION Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/13/1987 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
02/21/2019 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/06/2015 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

04/30/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/06/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/23/1993 SUPPL-4 Labeling

Label is not available on this site.

04/03/1990 SUPPL-3 Labeling

Label is not available on this site.

03/09/1990 SUPPL-2 Labeling

Label is not available on this site.

03/16/1989 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