Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018058
Company: CURIUM

Products on NDA 018058

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018058

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.

Therapeutic Equivalents for NDA 018058

GALLIUM CITRATE GA 67

There are no Therapeutic Equivalents.