Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016666
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HIPPURAN I 131 IODOHIPPURATE SODIUM I-131 0.25mCi/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
05/24/1968 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
05/15/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/07/1982 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/1982 SUPPL-12 Labeling

Label is not available on this site.

04/07/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1977 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/27/1977 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/19/1975 SUPPL-6 Labeling

Label is not available on this site.

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