ANDA 210158

MICRO LABS

FDA Drug Application

Application #210158

Documents

• Letter: 2018-08-20
• Letter: 2019-02-21

Application Sponsors

ANDA 210158

MICRO LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

10MG

0

DALFAMPRIDINE

DALFAMPRIDINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-03-11	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-08-14	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-09-15	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MICRO LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210158
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DALFAMPRIDINE","activeIngredients":"DALFAMPRIDINE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210158Orig1s000TAltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210158Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/14\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-14
        )

)