Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020624
Company: VALIDUS PHARMS
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANZEMET | DOLASETRON MESYLATE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ANZEMET | DOLASETRON MESYLATE | 12.5MG/0.625ML (20MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ANZEMET | DOLASETRON MESYLATE | 500MG/25ML (20MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/18/2014 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020624s025lbl.pdf | |
| 09/16/2013 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020623s010lbl.pdf,020624s023lbl.pdf | |
| 09/22/2011 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020624s022lbl.pdf | |
| 10/06/2009 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020624s020lbl.pdf | |
| 05/30/2007 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020623s006,020624s016lbl.pdf | |
| 06/01/2005 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020624s013lbl.pdf |