`
` SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP?U=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS&APPLNO=020262)
`
` TWEET (HTTPS://TWITTER.COM/INTENT/TWEET/?TEXT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS&APPLNO=020262)
`
`
`
`EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS&APPLNO=020262)
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 020262
`Company: HQ SPCLT PHARMA
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS%26VARAPPLNO=020262)
`
`Products on NDA 020262
`
`CSV
`
`Excel
`
`
`Drug
`Name
`
`Active
`Ingredients
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`RS
`
`TAXOL
`
`PACLITAXEL
`
`6MG/ML
`
`INJECTABLE;INJECTION
`
`Prescription
`
`AP
`
`Yes
`
`No
`
`Showing 1 to 1 of 1 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020262
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews,
`Labels, Patient
`Package Insert
`
`12/29/1992
`
`ORIG-1
`
`Approval
`
`Type 1 - New
`Molecular Entity
`
`PRIORITY;
`Orphan
`
`Notes
`
`Label is not
`available on
`this site.
`
`
`
`
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`NEPTUNE GENERICS EX. 1025 00001
`
`
`
`Action
`Date
`
`Submission
`
`03/03/2015
`
`SUPPL-51
`
`06/27/2014
`
`SUPPL-50
`
`Supplement
`Categories
`or Approval
`Type
`
`Labeling-
`Package Insert,
`Labeling-
`Container/Carton
`Labels
`
`Manufacturing
`(CMC)
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020262s051lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020262Orig1s051
`
`05/02/2011
`
`SUPPL-49
`
`Labeling,
`Labeling-
`Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020262s049ltr.pdf
`
`08/13/2010
`
`SUPPL-48
`
`Labeling
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020262s048lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020262s048ltr.pdf
`Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020262Orig1s048.pdf)
`
`03/05/2003
`
`SUPPL-41
`
`Labeling
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20262slr041ltr.pd
`
`12/12/2002
`
`SUPPL-42
`
`Manufacturing
`(CMC)-
`Packaging
`
`08/29/2002
`
`SUPPL-35
`
`Labeling
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262slr035ltr.pd
`
`03/04/2002
`
`SUPPL-38
`
`Labeling
`
`03/04/2002
`
`SUPPL-37
`
`Labeling
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262s36s37s38lt
`Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020262s036,037,038_T
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262s36s37s38lt
`Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020262s036,037,038_T
`
`05/23/2001
`
`SUPPL-40
`
`Manufacturing
`(CMC)-Control
`
`NEPTUNE GENERICS EX. 1025 00002
`
`
`
`Action
`Date
`
`Submission
`
`04/10/2001
`
`SUPPL-39
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)
`
`06/20/2000
`
`SUPPL-36
`
`Efficacy-New
`Dosing Regimen
`
`12/10/1999
`
`SUPPL-32
`
`Labeling
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20262S36LBL.PDF)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20262S36LTR.PD
`Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020262s036,037,038_T
`
`10/25/1999
`
`SUPPL-33
`
`Efficacy-New
`Indication
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20262S33LBL.PDF)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20262S33LTR.PD
`
`03/19/1999
`
`SUPPL-30
`
`Manufacturing
`(CMC)-Control
`
`01/08/1999
`
`SUPPL-31
`
`Labeling
`
`Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf)
`
`01/08/1999
`
`SUPPL-21
`
`Labeling
`
`Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf)
`
`01/08/1999
`
`SUPPL-16
`
`Labeling
`
`Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf)
`
`01/08/1999
`
`SUPPL-14
`
`Labeling
`
`Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf)
`
`11/05/1998
`
`SUPPL-29
`
`Manufacturing
`(CMC)
`
`NEPTUNE GENERICS EX. 1025 00003
`
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262s24
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262s24ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20262s024.cfm)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slb
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf)
`Review
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020262s026s027s028.cfm
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slb
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf)
`Review
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020262s026s027s028.cfm
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slb
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf)
`Review
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020262s026s027s028.cfm
`
`Action
`Date
`
`Submission
`
`06/30/1998
`
`SUPPL-24
`
`Supplement
`Categories
`or Approval
`Type
`
`Efficacy-New
`Indication
`
`04/09/1998
`
`SUPPL-28
`
`Labeling
`
`04/09/1998
`
`SUPPL-27
`
`Labeling
`
`04/09/1998
`
`SUPPL-26
`
`Efficacy-New
`Indication
`
`04/01/1998
`
`SUPPL-23
`
`Manufacturing
`(CMC)-Control
`
`12/19/1997
`
`SUPPL-25
`
`Manufacturing
`(CMC)-Control
`
`09/18/1997
`
`SUPPL-18
`
`Manufacturing
`(CMC)
`
`08/04/1997
`
`SUPPL-22
`
`Efficacy-New
`Indication
`
`04/25/1997
`
`SUPPL-19
`
`Manufacturing
`(CMC)
`
`03/05/1997
`
`SUPPL-17
`
`Manufacturing
`(CMC)
`
`NEPTUNE GENERICS EX. 1025 00004
`
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action
`Date
`
`Submission
`
`12/13/1996
`
`SUPPL-15
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)-
`Packaging
`
`04/03/1996
`
`SUPPL-13
`
`Manufacturing
`(CMC)-Control
`
`04/01/1996
`
`SUPPL-12
`
`Labeling
`
`05/05/1995
`
`SUPPL-11
`
`02/15/1995
`
`SUPPL-10
`
`Manufacturing
`(CMC)-
`Formulation
`
`Manufacturing
`(CMC)-Control
`
`10/19/1994
`
`SUPPL-8
`
`Manufacturing
`(CMC)
`
`07/22/1994
`
`SUPPL-9
`
`Manufacturing
`(CMC)
`
`06/22/1994
`
`SUPPL-3
`
`Efficacy-New
`Dosing Regimen
`
`04/21/1994
`
`SUPPL-7
`
`Manufacturing
`(CMC)-Control
`
`04/13/1994
`
`SUPPL-4
`
`Efficacy-New
`Indication
`
`NEPTUNE GENERICS EX. 1025 00005
`
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action
`Date
`
`Submission
`
`03/16/1994
`
`SUPPL-5
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)
`
`07/23/1993
`
`SUPPL-2
`
`Labeling
`
`06/25/1993
`
`SUPPL-1
`
`Manufacturing
`(CMC)
`
`Showing 1 to 43 of 43 entries
`
`Labels for NDA 020262
`
`Therapeutic Equivalents for NDA 020262
`
`
`
`
`
`NEPTUNE GENERICS EX. 1025 00006
`
`