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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012967
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORAGRAFIN SODIUM IPODATE SODIUM 500MG 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
06/25/1962 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/17/1992 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/13/1988 SUPPL-35 Labeling

Label is not available on this site.

09/25/1986 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/25/1985 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/29/1985 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/30/1982 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/10/1982 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/18/1980 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/18/1980 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/13/1979 SUPPL-23 Labeling

Label is not available on this site.

04/17/1979 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1978 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/1978 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1978 SUPPL-18 Labeling

Label is not available on this site.

06/07/1978 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1977 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/07/1978 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1976 SUPPL-14 Labeling

Label is not available on this site.

12/19/1975 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1975 SUPPL-12 Labeling

Label is not available on this site.

12/19/1975 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1975 SUPPL-9 Labeling

Label is not available on this site.

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