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| TAXOL | PACLITAXEL | 6MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/29/1992 | 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 |
|---|---|---|---|---|---|
| 03/03/2015 | SUPPL-51 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020262s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020262Orig1s051ltr.pdf | |
| 06/27/2014 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/2011 | SUPPL-49 | Labeling-Package Insert, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020262s049ltr.pdf | |
| 08/13/2010 | SUPPL-48 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020262s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020262s048ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020262Orig1s048.pdf | |
| 12/12/2002 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/05/2003 | SUPPL-41 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20262slr041ltr.pdf |
| 05/23/2001 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/2001 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/2002 | SUPPL-38 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262s36s37s38ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020262s036,037,038_Taxol.pdf |
| 03/04/2002 | SUPPL-37 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262s36s37s38ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020262s036,037,038_Taxol.pdf |
| 06/20/2000 | SUPPL-36 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20262S36LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20262S36LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020262s036,037,038_Taxol.pdf | |
| 08/29/2002 | SUPPL-35 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262slr035ltr.pdf |
| 10/25/1999 | SUPPL-33 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20262S33LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20262S33LTR.PDF | |
| 12/10/1999 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 01/08/1999 | SUPPL-31 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf |
| 03/19/1999 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1998 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020262s026s027s028.cfm | |
| 04/09/1998 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020262s026s027s028.cfm | |
| 04/09/1998 | SUPPL-26 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020262s026s027s028.cfm | |
| 12/19/1997 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1998 | SUPPL-24 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262s24lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262s24ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20262s024.cfm | |
| 04/01/1998 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/04/1997 | SUPPL-22 | Efficacy-New Indication |
Label is not available on this site. |
||
| 01/08/1999 | SUPPL-21 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf |
| 04/25/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1999 | SUPPL-16 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf |
| 12/13/1996 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/08/1999 | SUPPL-14 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf |
| 04/03/1996 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/05/1995 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/15/1995 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/22/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/19/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1994 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1994 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/22/1994 | SUPPL-3 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 07/23/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/25/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| 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 |