NDA 203479

TASMAN PHARMA

FDA Drug Application

Application #203479

Documents

• Letter: 2013-12-09
• Letter: 2013-08-23
• Letter: 2015-09-17
• Letter: 2015-10-02
• Label: 2014-01-13
• Label: 2013-08-27
• Label: 2015-09-16
• Other: 2013-02-08
• Letter: 2013-02-08
• Letter: 2015-09-17
• Label: 2013-02-08
• Label: 2015-09-16
• Label: 2015-12-10
• Review: 2013-09-20
• Summary Review: 2013-09-20
• Label: 2017-02-27
• Letter: 2017-03-02
• Letter: 2019-01-22
• Label: 2020-04-15
• Letter: 2020-04-15
• Letter: 2020-07-30
• Label: 2020-07-30
• Letter: 2021-02-22
• Letter: 2021-08-02
• Letter: 2021-11-12

Application Sponsors

NDA 203479

TASMAN PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

50MG/ML

1

VERSACLOZ

CLOZAPINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2013-02-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2013-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2014-03-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2014-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2016-02-18	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-09-15	STANDARD
REMS; REMS	SUPPL	8	AP	2015-09-15	N/A
LABELING; Labeling	SUPPL	9	AP	2015-09-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	2017-02-23	901 REQUIRED
REMS; REMS	SUPPL	11	AP	2019-01-16	N/A
LABELING; Labeling	SUPPL	12	AP	2020-07-29	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-04-14	901 REQUIRED
REMS; REMS	SUPPL	15	AP	2021-02-18	N/A
REMS; REMS	SUPPL	16	AP	2021-07-29	N/A
REMS; REMS	SUPPL	17	AP	2021-11-10	N/A

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	6
SUPPL	8	Null	6
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	6
SUPPL	12	Null	6
SUPPL	14	Null	7
SUPPL	15	Null	6
SUPPL	16	Null	6
SUPPL	17	Null	7

CDER Filings

TASMAN PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203479
            [companyName] => TASMAN PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERSACLOZ","activeIngredients":"CLOZAPINE","strength":"50MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/29\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203479s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203479s014lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203479s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2015","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021590s028,203479s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2015","submission":"SUPPL-8","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203479s007s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203479s007s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/05\/2013","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203479Orig1s001Lbl.pdf\"}]","notes":""},{"actionDate":"12\/05\/2013","submission":"SUPPL-1","supplementCategories":"REMS-Assessment","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203479Orig1s001Lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203479s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203479s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/06\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203479s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203479Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203479_versacloz_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203479Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/14\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203479s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/203479Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"07\/29\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203479s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/203479Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"01\/16\/2019","submission":"SUPPL-11","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203479Orig1s011ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/23\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203479s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203479Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"09\/30\/2015","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021590s028,203479s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/021590Orig1s028,203479Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"09\/15\/2015","submission":"SUPPL-8","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203479s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203479Orig1s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"09\/15\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203479s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203479Orig1s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"02\/18\/2016","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/29\/2014","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/25\/2014","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/22\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203479s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203479Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"12\/05\/2013","submission":"SUPPL-1","supplementCategories":"REMS-Modified, REMS-Assessment","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203479Orig1s001Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203479Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-07-29
        )

)