Drugs@FDA: FDA-Approved Drugs
Company: JUBILANT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DRAXIMAGE MDP-10 | TECHNETIUM TC-99M MEDRONATE | N/A | INJECTABLE;INJECTION | Discontinued | None | No | No |
DRAXIMAGE MDP-25 | TECHNETIUM TC-99M MEDRONATE | N/A | INJECTABLE;INJECTION | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
11/28/1978 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18-035_Technescan%20MDP.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/23/2011 | SUPPL-32 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018035s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018035s032ltr.pdf | |
10/22/2010 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018035s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018035s029ltr.pdf | |
07/08/2009 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018035s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018035s024ltr.pdf | |
02/27/2004 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18035scr018ltr.pdf |
07/03/2002 | SUPPL-17 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18035scm017ltr.pdf |
04/02/1999 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
04/02/1999 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
08/23/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
12/30/1994 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/31/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
12/08/1988 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/15/1979 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
04/26/1979 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/29/1980 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/30/1980 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/23/2011 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018035s032lbl.pdf | |
10/22/2010 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018035s029lbl.pdf | |
07/08/2009 | SUPPL-24 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018035s024lbl.pdf |