ANDA 211941

DR REDDYS LABS LTD

FDA Drug Application

Application #211941

Documents

• Letter: 2019-08-07

Application Sponsors

ANDA 211941

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.25MG BASE/ML

0

CARBOPROST TROMETHAMINE

CARBOPROST TROMETHAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-07-02

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211941
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBOPROST TROMETHAMINE","activeIngredients":"CARBOPROST TROMETHAMINE","strength":"EQ 0.25MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/02\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211941Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-02
        )

)