Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019058
Company: ASTRAZENECA

Products on NDA 019058

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TENORMIN	ATENOLOL	0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019058

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.