Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020134
Company: Q BIOMED
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 |