Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020119
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English