ANDA 202240

LUPIN LTD

FDA Drug Application

Application #202240

Documents

• Letter: 2015-06-11
• Label: 2015-06-19
• Letter: 2015-04-10

Application Sponsors

ANDA 202240

LUPIN LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	50MG	0	CELECOXIB	CELECOXIB
002	CAPSULE;ORAL	100MG	0	CELECOXIB	CELECOXIB
003	CAPSULE;ORAL	200MG	0	CELECOXIB	CELECOXIB
004	CAPSULE;ORAL	400MG	0	CELECOXIB	CELECOXIB

FDA Submissions

	ORIG	1	AP	2014-10-29
	ORIG	2	AP	2015-06-09
LABELING; Labeling	SUPPL	4	AP	2019-10-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2019-10-09	UNKNOWN
LABELING; Labeling	SUPPL	8	AP	2019-10-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-01-05	STANDARD

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Null	15
SUPPL	4	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	11	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202240
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/29\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202240Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/09\/2015","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/29\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202240Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202240Orig1s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202240Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/09\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/09\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/09\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/16\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-09
        )

)