Drugs@FDA: FDA-Approved Drugs
Company: CURIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THALLOUS CHLORIDE TL 201 | THALLOUS CHLORIDE TL-201 | 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 |
---|---|---|---|---|---|---|---|
10/23/1979 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/13/2016 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018150s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018150Orig1s027ltr.pdf | |
01/12/2012 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018150s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018150s026ltr.pdf | |
06/22/2011 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018150s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018150s025ltr.pdf | |
04/16/2004 | SUPPL-20 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18150scs020ltr.pdf |
07/23/2004 | SUPPL-19 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18150s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18150s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018150_S019_Thallous Chloride T1-201_APPROVAL_PACKAGE.pdf | |
06/03/2002 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/27/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/22/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
02/18/1997 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
03/30/1994 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
12/16/1993 | SUPPL-10 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
07/13/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
09/12/1984 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/27/1981 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/07/1982 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/13/1980 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/13/2016 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018150s027lbl.pdf | |
01/12/2012 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018150s026lbl.pdf | |
06/22/2011 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018150s025lbl.pdf | |
07/23/2004 | SUPPL-19 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18150s019lbl.pdf |
THALLOUS CHLORIDE TL 201
INJECTABLE;INJECTION; 1mCi/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
THALLOUS CHLORIDE TL 201 | THALLOUS CHLORIDE TL-201 | 1mCi/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018150 | CURIUM |