Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020119
Company: HQ SPECLT PHARMA
Company: HQ SPECLT PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VUMON | TENIPOSIDE | 10MG/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
07/14/1992 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/02/2015 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020119s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020119Orig1s013ltr.pdf | |
02/26/2013 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/20/2011 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020119s010,s011ltr.pdf | |
10/20/2011 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020119s010s011ltr.pdf | |
02/10/2009 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020119s009ltr.pdf |
01/28/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/17/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/05/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/01/2002 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20119slr004ltr.pdf |
03/03/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/28/1992 | SUPPL-1 | 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 |
---|---|---|---|---|---|
03/02/2015 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020119s013lbl.pdf | |
10/20/2011 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf | |
10/20/2011 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf |