Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017685
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CONRAY 325 IOTHALAMATE SODIUM 54.3% 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
09/07/1976 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
01/13/1995 SUPPL-15 Labeling

Label is not available on this site.

08/28/1992 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1992 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1990 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1992 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1989 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1989 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/05/1985 SUPPL-8 Labeling

Label is not available on this site.

12/04/1984 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/13/2009 SUPPL-5 Labeling

Label is not available on this site.

08/24/1981 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/13/2009 SUPPL-3 Labeling

Label is not available on this site.

09/06/1978 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1979 SUPPL-1 Labeling

Label is not available on this site.

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