Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017546
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIPRIDE SODIUM NITROPRUSSIDE 50MG/VIAL 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
05/10/1974 ORIG-1 Approval Type 1 - New Molecular Entity 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
10/18/1990 SUPPL-23 Labeling

Label is not available on this site.

05/27/1987 SUPPL-21 Labeling

Label is not available on this site.

07/30/1984 SUPPL-18 Labeling

Label is not available on this site.

05/15/1985 SUPPL-12 Labeling

Label is not available on this site.

02/13/1981 SUPPL-10 Labeling

Label is not available on this site.

01/23/1979 SUPPL-9 Labeling

Label is not available on this site.

12/27/1977 SUPPL-6 Labeling

Label is not available on this site.

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