Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018511
Company: JUBILANT
Company: JUBILANT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DRAXIMAGE DTPA | TECHNETIUM TC-99M PENTETATE KIT | 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 |
---|---|---|---|---|---|---|---|
12/29/1989 | 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 |
---|---|---|---|---|---|
06/07/2023 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018511Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018511Orig1s032ltr.pdf | |
10/12/2022 | SUPPL-31 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018511Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018511Orig1s031ltr.pdf | |
12/26/2017 | SUPPL-28 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018511s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018511Orig1s028ltr.pdf | |
01/05/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/27/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/28/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/22/2017 | SUPPL-20 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021555Origs020lbl.pdf | ||
09/23/2011 | SUPPL-19 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018511s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018511s019ltr.pdf | |
12/10/2001 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/02/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
04/02/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
08/23/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
08/09/1994 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/30/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/07/1990 | 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 |
---|---|---|---|---|---|
06/07/2023 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018511Orig1s032lbl.pdf | |
10/12/2022 | SUPPL-31 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018511Orig1s031lbl.pdf | |
10/12/2022 | SUPPL-31 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018511Orig1s031lbl.pdf | |
10/12/2022 | SUPPL-31 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018511Orig1s031lbl.pdf | |
10/12/2022 | SUPPL-31 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018511Orig1s031lbl.pdf | |
12/26/2017 | SUPPL-28 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018511s028lbl.pdf | |
12/22/2017 | SUPPL-20 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021555Origs020lbl.pdf | |
09/23/2011 | SUPPL-19 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018511s019lbl.pdf |