Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018537
Company: HOSPIRA
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
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.

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