Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071910
Company: MALLINKRODT NUCLEAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM IODIDE I 123 SODIUM IODIDE I-123 200uCi CAPSULE;ORAL Prescription AA 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
02/28/1989 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/29/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/18/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/18/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

SODIUM IODIDE I 123

CAPSULE;ORAL; 200uCi
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM IODIDE I 123 SODIUM IODIDE I-123 200uCi CAPSULE;ORAL Prescription Yes AA 018671 CARDINAL HEALTH 418
SODIUM IODIDE I 123 SODIUM IODIDE I-123 200uCi CAPSULE;ORAL Prescription No AA 071910 MALLINKRODT NUCLEAR

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