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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020134
Company: Q BIOMED

Products on NDA 020134

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METASTRON	STRONTIUM CHLORIDE SR-89	1mCi/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020134

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/18/1993	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2013	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020134s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020134Orig1s012ltr.pdf
04/03/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/24/1999	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/30/1996	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
01/07/1997	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/20/1995	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/10/1997	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020134

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2013	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020134s012lbl.pdf

Therapeutic Equivalents for NDA 020134

METASTRON

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

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