NDA 203076

CIPLA LTD

FDA Drug Application

Application #203076

Documents

• Letter: 2012-10-18

Application Sponsors

NDA 203076

CIPLA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL SUSPENSION

30MG; 50MG; 60MG

0

LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE

LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE

FDA Submissions

TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination

ORIG

1

TA

2012-10-16

STANDARD

Submissions Property Types

ORIG

1

Null

23

CDER Filings

CIPLA LTD

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(
    [0] => Array
        (
            [ApplNo] => 203076
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE","activeIngredients":"LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE","strength":"30MG; 50MG; 60MG","dosageForm":"TABLET; ORAL SUSPENSION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/16\/2012","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 3 - New Dosage Form and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/203076Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-10-16
        )

)