Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016708
Company: MALLINKRODT NUCLEAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM CHROMATE CR 51 SODIUM CHROMATE CR-51 100uCi/ML 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
12/23/1971 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
08/28/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/20/1997 SUPPL-14 Labeling

Label is not available on this site.

10/25/1995 SUPPL-12 Labeling

Label is not available on this site.

06/28/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/22/1984 SUPPL-9 Labeling

Label is not available on this site.

05/07/1982 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1980 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/23/1977 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/29/1977 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/17/1975 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

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