Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018058
Company: CURIUM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GALLIUM CITRATE GA 67 GALLIUM CITRATE GA-67 2mCi/ML INJECTABLE;INJECTION Prescription BS 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
02/01/1979 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
03/19/2014 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/22/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/14/1982 SUPPL-8 Labeling

Label is not available on this site.

09/27/1982 SUPPL-7 Labeling

Label is not available on this site.

03/08/1984 SUPPL-5 Labeling

Label is not available on this site.

05/07/1982 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1981 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/04/1980 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/04/1980 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

GALLIUM CITRATE GA 67

There are no Therapeutic Equivalents.

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