Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018335
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMERSCAN MDP KIT TECHNETIUM TC-99M MEDRONATE KIT N/A 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
08/05/1982 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
08/24/1988 SUPPL-2 Labeling

Label is not available on this site.

09/18/1986 SUPPL-1 Labeling

Label is not available on this site.

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