Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018537
Company: HOSPIRA

Products on NDA 018537

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIDIL	NITROGLYCERIN	5MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
TRIDIL	NITROGLYCERIN	0.5MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018537

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/1981	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
11/05/2001	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
12/09/1998	SUPPL-15	Labeling		Label is not available on this site.
12/15/1995	SUPPL-13	Labeling		Label is not available on this site.
02/22/1995	SUPPL-12	Labeling		Label is not available on this site.
07/25/1994	SUPPL-11	Labeling		Label is not available on this site.
07/03/1991	SUPPL-10	Labeling		Label is not available on this site.
11/17/1986	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/22/1984	SUPPL-8	Labeling		Label is not available on this site.
08/22/1984	SUPPL-7	Manufacturing (CMC)-Formulation		Label is not available on this site.
07/08/1983	SUPPL-5	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
01/12/1984	SUPPL-4	Labeling		Label is not available on this site.
06/24/1983	SUPPL-3	Manufacturing (CMC)-Formulation		Label is not available on this site.
06/16/1983	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
03/09/1982	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.