Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018671
Company: CARDINAL HEALTH 418
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM IODIDE I 123 SODIUM IODIDE I-123 100uCi CAPSULE;ORAL Prescription AA Yes Yes
SODIUM IODIDE I 123 SODIUM IODIDE I-123 200uCi CAPSULE;ORAL Prescription AA Yes Yes
SODIUM IODIDE I 123 SODIUM IODIDE I-123 400uCi CAPSULE;ORAL 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
05/27/1982 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
06/13/2008 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018671s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018671s016ltr.pdf
10/19/2000 SUPPL-10 Labeling

Label is not available on this site.

02/02/1998 SUPPL-9 Labeling

Label is not available on this site.

01/23/1998 SUPPL-8 Labeling

Label is not available on this site.

11/04/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/28/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/17/1994 SUPPL-5 Labeling

Label is not available on this site.

07/12/1988 SUPPL-4 Labeling

Label is not available on this site.

12/31/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/12/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/09/1985 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/13/2008 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018671s016lbl.pdf

SODIUM IODIDE I 123

CAPSULE;ORAL; 100uCi
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 100uCi CAPSULE;ORAL Prescription Yes AA 018671 CARDINAL HEALTH 418
SODIUM IODIDE I 123 SODIUM IODIDE I-123 100uCi CAPSULE;ORAL Prescription No AA 071909 MALLINKRODT NUCLEAR

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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