ANDA 209959

CIPLA

FDA Drug Application

Application #209959

Documents

• Letter: 2020-05-14

Application Sponsors

ANDA 209959

CIPLA

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, METERED;INHALATION

EQ 0.09MG BASE/INH

0

ALBUTEROL SULFATE

ALBUTEROL SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-04-08	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-11-04	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-10-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	7	Null	15
SUPPL	10	Null	15

TE Codes

001

Prescription

AB1

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209959
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.09MG BASE\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209959Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-08
        )

)