Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016089
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RUBRATOPE-57 CYANOCOBALAMIN CO-57 0.5-1uCi CAPSULE;ORAL Discontinued None No No
RUBRATOPE-57 KIT COBALT CHLORIDE CO-57; CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR N/A;N/A;N/A;N/A N/A;N/A 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
12/21/1970 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
07/20/2001 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/21/1994 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1985 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/29/1984 SUPPL-26 Labeling

Label is not available on this site.

05/29/1984 SUPPL-25 Labeling

Label is not available on this site.

01/22/1980 SUPPL-23 Labeling

Label is not available on this site.

03/03/1981 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/03/1981 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/08/1979 SUPPL-20 Labeling

Label is not available on this site.

08/06/1979 SUPPL-19 Labeling

Label is not available on this site.

05/12/1978 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1978 SUPPL-17 Labeling

Label is not available on this site.

08/04/1977 SUPPL-16 Labeling

Label is not available on this site.

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