Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075941
Company: BIO NUCLEONICS
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
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.

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 BIO NUCLEONICS

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