Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017725
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM PERTECHNETATE TC 99M TECHNETIUM TC-99M SODIUM PERTECHNETATE 10-60mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INJECTION, ORAL Discontinued None Yes No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
12/30/1977 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
09/09/1986 SUPPL-10 Efficacy-New Indication

Label is not available on this site.

07/20/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/19/1989 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/09/1986 SUPPL-5 Labeling

Label is not available on this site.

10/05/1982 SUPPL-4 Labeling

Label is not available on this site.

04/18/1983 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1979 SUPPL-2 Labeling

Label is not available on this site.

01/10/1979 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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