HQ SPCLT PHARMA FDA Approval NDA 020262

Application #020262

Documents

Letter	1998-04-09
Letter	2003-03-26
Label	1998-06-30
Label	1998-04-09
Label	1998-04-09
Label	1999-10-25
Label	2010-08-28
Label	2015-03-05
Review	1999-01-08
Review	2000-06-15
Review	2005-12-16
Letter	1998-06-30
Letter	1998-04-09
Letter	1998-04-09
Letter	1999-10-25
Letter	2002-08-29
Letter	2000-06-20
Letter	2002-03-04
Letter	2002-03-04
Letter	2010-09-07
Letter	2011-05-04
Letter	2015-03-04
Label	1998-04-09
Label	2000-06-20
Label	2011-05-02
Review	1999-01-08
Review	1999-01-08
Review	1999-09-09
Review	2000-06-15
Review	2000-06-15
Review	2000-07-06
Review	2005-12-16
Review	2005-12-16
Review	2018-04-18

Application Sponsors

NDA 020262

HQ SPCLT PHARMA

Marketing Status

Discontinued

001

Application Products

001

INJECTABLE;INJECTION

6MG/ML

TAXOL

PACLITAXEL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1992-12-29	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1993-07-23	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	1994-06-22	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	1994-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-03-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1994-04-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-10-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1994-07-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-02-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-05-05	PRIORITY
LABELING; Labeling	SUPPL	12	AP	1996-04-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1996-04-03	PRIORITY
LABELING; Labeling	SUPPL	14	AP	1999-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-12-13	PRIORITY
LABELING; Labeling	SUPPL	16	AP	1999-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1997-03-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1997-09-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1997-04-25	PRIORITY
LABELING; Labeling	SUPPL	21	AP	1999-01-08	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	1997-08-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1998-04-01	PRIORITY
EFFICACY; Efficacy	SUPPL	24	AP	1998-06-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1997-12-19	PRIORITY
EFFICACY; Efficacy	SUPPL	26	AP	1998-04-09	PRIORITY
LABELING; Labeling	SUPPL	27	AP	1998-04-09	PRIORITY
LABELING; Labeling	SUPPL	28	AP	1998-04-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1998-11-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1999-03-19	PRIORITY
LABELING; Labeling	SUPPL	31	AP	1999-01-08	STANDARD
LABELING; Labeling	SUPPL	32	AP	1999-12-10	STANDARD
EFFICACY; Efficacy	SUPPL	33	AP	1999-10-25	PRIORITY
LABELING; Labeling	SUPPL	35	AP	2002-08-29	STANDARD
EFFICACY; Efficacy	SUPPL	36	AP	2000-06-20	PRIORITY
LABELING; Labeling	SUPPL	37	AP	2002-03-04	PRIORITY
LABELING; Labeling	SUPPL	38	AP	2002-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2001-04-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2001-05-23	PRIORITY
LABELING; Labeling	SUPPL	41	AP	2003-03-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	2002-12-12	PRIORITY
LABELING; Labeling	SUPPL	48	AP	2010-08-13	STANDARD
LABELING; Labeling	SUPPL	49	AP	2011-05-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	2014-06-27	PRIORITY
LABELING; Labeling	SUPPL	51	AP	2015-03-03	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	5	Null	14
SUPPL	7	Null	14
SUPPL	8	Null	14
SUPPL	9	Null	14
SUPPL	10	Null	14
SUPPL	11	Null	14
SUPPL	13	Null	14
SUPPL	15	Null	14
SUPPL	17	Null	14
SUPPL	18	Null	14
SUPPL	19	Null	14
SUPPL	23	Null	14
SUPPL	25	Null	14
SUPPL	27	Null	14
SUPPL	28	Null	14
SUPPL	29	Null	14
SUPPL	30	Null	14
SUPPL	37	Null	14
SUPPL	39	Null	14
SUPPL	40	Null	14
SUPPL	42	Null	14
SUPPL	48	Null	7
SUPPL	49	Null	6
SUPPL	50	Null	14
SUPPL	51	Null	7

CDER Filings

HQ SPCLT PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20262
            [companyName] => HQ SPCLT PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAXOL","activeIngredients":"PACLITAXEL","strength":"6MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/03\/2015","submission":"SUPPL-51","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020262s051lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2015","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020262s051lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2011","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020262s049lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2011","submission":"SUPPL-49","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020262s049lbl.pdf\"}]","notes":""},{"actionDate":"08\/13\/2010","submission":"SUPPL-48","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020262s048lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2000","submission":"SUPPL-36","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20262S36LBL.PDF\"}]","notes":""},{"actionDate":"10\/25\/1999","submission":"SUPPL-33","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20262S33LBL.PDF\"}]","notes":""},{"actionDate":"06\/30\/1998","submission":"SUPPL-24","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20262s24lbl.pdf\"}]","notes":""},{"actionDate":"04\/09\/1998","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20262slbl.pdf\"}]","notes":""},{"actionDate":"04\/09\/1998","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20262slbl.pdf\"}]","notes":""},{"actionDate":"04\/09\/1998","submission":"SUPPL-26","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20262slbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TAXOL","submission":"PACLITAXEL","actionType":"6MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-03-03
        )

)

NDA 020262

HQ SPCLT PHARMA

FDA Drug Application

Application #020262

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

HQ SPCLT PHARMA