ANDA 211750

GLENMARK PHARMS LTD

FDA Drug Application

Application #211750

Documents

• Letter: 2019-01-18

Application Sponsors

ANDA 211750

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

0.2%

0

HYDROCORTISONE VALERATE

HYDROCORTISONE VALERATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-12-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211750
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE VALERATE","activeIngredients":"HYDROCORTISONE VALERATE","strength":"0.2%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/14\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/211750Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-14
        )

)