Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017807
Company: NEW RIVER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROFERDEX IRON DEXTRAN EQ 50MG IRON/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
03/26/1981 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
03/06/1989 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/1986 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/1984 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1986 SUPPL-3 Labeling

Label is not available on this site.

01/04/1984 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/05/1982 SUPPL-1 Labeling

Label is not available on this site.

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