Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018450
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROPRESS SODIUM NITROPRUSSIDE 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
09/08/1981 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/1990 SUPPL-9 Labeling

Label is not available on this site.

02/20/1990 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/25/1986 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1984 SUPPL-3 Labeling

Label is not available on this site.

01/23/1984 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/31/1991 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

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