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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017700
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GALLIUM CITRATE GA 67 GALLIUM CITRATE GA-67 1mCi/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
12/16/1977 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
08/23/1978 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1979 SUPPL-2 Labeling

Label is not available on this site.

08/23/1978 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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