ANDA 077798

DR REDDYS LABS INC

FDA Drug Application

Application #077798

Documents

• Letter: 2011-05-10

Application Sponsors

ANDA 077798

DR REDDYS LABS INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	TABLET; ORAL	5MG	0	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE
002	TABLET; ORAL	10MG	0	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE
003	TABLET; ORAL	20MG	0	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE

FDA Submissions

ORIG

1

TA

2007-07-16

Submissions Property Types

ORIG

1

Null

0

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77798
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"10MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"20MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESCITALOPRAM OXALATE","submission":"ESCITALOPRAM OXALATE","actionType":"5MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ESCITALOPRAM OXALATE","submission":"ESCITALOPRAM OXALATE","actionType":"10MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ESCITALOPRAM OXALATE","submission":"ESCITALOPRAM OXALATE","actionType":"20MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)