Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020262
Company: HQ SPCLT PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAXOL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription AP 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-Package Insert, Labeling-Container/Carton Labels 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, Labeling-Package Insert 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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020262s051lbl.pdf
03/03/2015 SUPPL-51 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020262s051lbl.pdf
05/02/2011 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf
05/02/2011 SUPPL-49 Labeling-Package Insert 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

TAXOL

INJECTABLE;INJECTION; 6MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PACITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 207326 GLAND PHARMA LTD
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 090130 ACTAVIS TOTOWA
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 077574 FRESENIUS KABI USA
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 076131 HOSPIRA
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 091540 MYLAN LABS LTD
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 078167 SANDOZ INC
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 075184 TEVA PHARMS
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 075190 WEST-WARD PHARMS INT
TAXOL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription Yes AP 020262 HQ SPCLT PHARMA

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