ANDA 204132

LUPIN LTD

FDA Drug Application

Application #204132

Documents

• Letter: 2015-08-25

Application Sponsors

ANDA 204132

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

1.5%

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-08-20
LABELING; Labeling	SUPPL	2	AP	2020-02-14	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-08-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	7

TE Codes

001

Prescription

AT

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204132
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"1.5%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/20\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204132Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/14\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-14
        )

)