Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017478
Company: LANTHEUS MEDCL
Company: LANTHEUS MEDCL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GALLIUM CITRATE GA 67 | GALLIUM CITRATE GA-67 | 2mCi/ML | INJECTABLE;INJECTION | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
05/17/1976 | 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 |
---|---|---|---|---|---|
08/06/2018 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017478s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017478Orig1s016ltr.pdf | |
03/09/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/21/2011 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017478s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017478s014ltr.pdf | |
03/03/2004 | SUPPL-13 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17478scs013ltr.pdf |
01/02/1987 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
08/15/1983 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/12/1982 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/31/1984 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
07/20/1978 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/21/1979 | SUPPL-4 | Efficacy |
Label is not available on this site. |
||
01/16/1979 | SUPPL-3 | 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 |
---|---|---|---|---|---|
08/06/2018 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017478s016lbl.pdf | |
10/21/2011 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017478s014lbl.pdf |