NDA 022479

HETERO DRUGS LTD

FDA Drug Application

Application #022479

Documents

• Letter: 2010-05-21

Application Sponsors

NDA 022479

HETERO DRUGS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

150MG/30MG

0

LAMIVUDINE AND STAVUDINE

LAMIVUDINE; STAVUDINE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2010-05-17

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

HETERO DRUGS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22479
            [companyName] => HETERO DRUGS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE AND STAVUDINE","activeIngredients":"LAMIVUDINE; STAVUDINE","strength":"150MG\/30MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMIVUDINE AND STAVUDINE","submission":"LAMIVUDINE; STAVUDINE","actionType":"150MG\/30MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)