Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019058
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TENORMIN ATENOLOL 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
09/13/1989 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/09/2005 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19058s017ltr.pdf
11/06/2003 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr028,19058slr016ltr.pdf
01/22/2003 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19058slr015ltr.pdf
10/19/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/21/1999 SUPPL-13 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18240-s026_tenormin.pdf
04/04/2000 SUPPL-12 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18240-s025_Tenormin.pdf
02/05/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/20/1996 SUPPL-10 Labeling

Label is not available on this site.

05/04/1994 SUPPL-8 Labeling

Label is not available on this site.

04/29/1993 SUPPL-7 Labeling

Label is not available on this site.

08/05/1992 SUPPL-6 Labeling

Label is not available on this site.

08/05/1992 SUPPL-5 Labeling

Label is not available on this site.

09/18/1991 SUPPL-4 Labeling

Label is not available on this site.

04/17/1991 SUPPL-3 Labeling

Label is not available on this site.

04/05/1991 SUPPL-2 Labeling

Label is not available on this site.

04/05/1991 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