Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 006799
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RUBRAMIN PC CYANOCOBALAMIN 0.1MG/ML INJECTABLE;INJECTION Discontinued None No No
RUBRAMIN PC CYANOCOBALAMIN 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
RUBRAMIN PC CYANOCOBALAMIN 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
09/29/1950 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
11/28/1995 SUPPL-15 Labeling

Label is not available on this site.

12/07/2007 SUPPL-14 Labeling

Label is not available on this site.

10/14/1987 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1986 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1984 SUPPL-11 Labeling

Label is not available on this site.

07/09/1984 SUPPL-10 Labeling

Label is not available on this site.

07/31/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/15/1983 SUPPL-8 Labeling

Label is not available on this site.

08/26/1980 SUPPL-7 Labeling

Label is not available on this site.

01/19/1979 SUPPL-6 Labeling

Label is not available on this site.

12/07/2007 SUPPL-4 Labeling

Label is not available on this site.

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