Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020262
Company: HQ SPCLT PHARMA
Company: HQ SPCLT PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TAXOL | PACLITAXEL | 6MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/03/2015 | SUPPL-51 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020262s051lbl.pdf | |
| 03/03/2015 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020262s051lbl.pdf | |
| 05/02/2011 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf | |
| 05/02/2011 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf | |
| 08/13/2010 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020262s048lbl.pdf | |
| 06/20/2000 | SUPPL-36 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20262S36LBL.PDF | |
| 10/25/1999 | SUPPL-33 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20262S33LBL.PDF | |
| 06/30/1998 | SUPPL-24 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262s24lbl.pdf | |
| 04/09/1998 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf | |
| 04/09/1998 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf | |
| 04/09/1998 | SUPPL-26 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf |