Drugs@FDA: FDA-Approved Drugs

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

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

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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