Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017471
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM PERTECHNETATE TC 99M TECHNETIUM TC-99M SODIUM PERTECHNETATE 2-100mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INJECTION, ORAL Discontinued None Yes No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
07/18/1974 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
01/22/1979 SUPPL-10 Labeling

Label is not available on this site.

07/20/1979 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/02/1983 SUPPL-8 Efficacy

Label is not available on this site.

02/21/1978 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1977 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1977 SUPPL-5 Labeling

Label is not available on this site.

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