Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020892
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VALSTAR PRESERVATIVE FREE | VALRUBICIN | 40MG/ML | SOLUTION;INTRAVESICAL | Prescription | AO | 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 |
---|---|---|---|---|---|---|---|
09/25/1998 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20892lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20892ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20892.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/07/2016 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020892s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020892Orig1s019ltr.pdf | |
01/17/2014 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/12/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/02/2013 | SUPPL-16 | Efficacy-Manufacturing Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020892Orig1s016ltr.pdf |
12/20/2012 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/02/2011 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020892s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020892s013ltr.pdf | |
04/24/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/05/1999 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/07/2016 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020892s019lbl.pdf | |
11/02/2011 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020892s013lbl.pdf | |
09/25/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20892lbl.pdf |
VALSTAR PRESERVATIVE FREE
SOLUTION;INTRAVESICAL; 40MG/ML
TE Code = AO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VALRUBICIN | VALRUBICIN | 40MG/ML | SOLUTION;INTRAVESICAL | Prescription | No | AO | 206430 | HIKMA |
VALSTAR PRESERVATIVE FREE | VALRUBICIN | 40MG/ML | SOLUTION;INTRAVESICAL | Prescription | Yes | AO | 020892 | ENDO OPERATIONS |