Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010929
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IODOTOPE SODIUM IODIDE I-131 1-130mCi CAPSULE;ORAL Discontinued None No No
IODOTOPE SODIUM IODIDE I-131 7-106mCi/BOT SOLUTION;ORAL Discontinued None No No
IODOTOPE SODIUM IODIDE I-131 1-150mCi 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
05/02/1957 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
08/14/2001 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

03/24/1998 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/1995 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/1995 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1985 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/22/1986 SUPPL-30 Labeling

Label is not available on this site.

08/08/1980 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/07/1980 SUPPL-27 Labeling

Label is not available on this site.

11/06/1979 SUPPL-26 Labeling

Label is not available on this site.

05/01/1979 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1978 SUPPL-24 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/14/1978 SUPPL-23 Labeling

Label is not available on this site.

09/14/1978 SUPPL-22 Labeling

Label is not available on this site.

09/14/1978 SUPPL-21 Labeling

Label is not available on this site.

01/22/1979 SUPPL-20 Labeling

Label is not available on this site.

02/23/1981 SUPPL-19 Labeling

Label is not available on this site.

12/14/1976 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1977 SUPPL-17 Labeling

Label is not available on this site.

03/07/1977 SUPPL-16 Labeling

Label is not available on this site.

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