Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075941
Company: Q BIOMED

Products on ANDA 075941

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STRONTIUM CHLORIDE SR-89	STRONTIUM CHLORIDE SR-89	1mCi/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075941

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/06/2003	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2013	SUPPL-11	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 075941

STRONTIUM CHLORIDE SR-89

INJECTABLE;INJECTION; 1mCi/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METASTRON	STRONTIUM CHLORIDE SR-89	1mCi/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020134	Q BIOMED
STRONTIUM CHLORIDE SR-89	STRONTIUM CHLORIDE SR-89	1mCi/ML	INJECTABLE;INJECTION	Prescription	No	AP	075941	Q BIOMED