FDA.reportPublic FDA data

Application 020262

Type
NDA
Sponsor
HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAXOLPACLITAXELINJECTABLE;INJECTION6MG/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44567-504PaclitaxelPaclitaxelWG Critical Care, LLCNDACurrent
44567-504PaclitaxelPaclitaxelWG Critical Care, LLCNDACurrent
44567-504PaclitaxelPaclitaxelWG Critical Care, LLCNDACurrent
44567-505PaclitaxelPaclitaxelWG Critical Care, LLCNDACurrent
44567-505PaclitaxelPaclitaxelWG Critical Care, LLCNDACurrent
44567-505PaclitaxelPaclitaxelWG Critical Care, LLCNDACurrent
44567-506PaclitaxelPaclitaxelWG Critical Care, LLCNDACurrent
44567-506PaclitaxelPaclitaxelWG Critical Care, LLCNDACurrent
44567-506PaclitaxelPaclitaxelWG Critical Care, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53723SUPPL2018-04-18
12391SUPPL2015-03-05
24685SUPPL2015-03-04
24684SUPPL2011-05-04
34447SUPPL2011-05-02
24683SUPPL2010-09-07
12390SUPPL2010-08-28
41250SUPPL2005-12-16
41249SUPPL2005-12-16
20575SUPPL2005-12-16
2264SUPPL2003-03-26
24679SUPPL2002-08-29
24682SUPPL2002-03-04
24681SUPPL2002-03-04
41248SUPPL2000-07-06
34446SUPPL2000-06-20
24680SUPPL2000-06-20
41247SUPPL2000-06-15
41246SUPPL2000-06-15
20574SUPPL2000-06-15
24678SUPPL1999-10-25
12389SUPPL1999-10-25
41245SUPPL1999-09-09
41244SUPPL1999-01-08
41243SUPPL1999-01-08
20573SUPPL1999-01-08
24675SUPPL1998-06-30
12386SUPPL1998-06-30
34445SUPPL1998-04-09
24677SUPPL1998-04-09
24676SUPPL1998-04-09
12388SUPPL1998-04-09
12387SUPPL1998-04-09
2263SUPPL1998-04-09