UPSHER SMITH LABS FDA Approval ANDA 077759

ANDA 077759

UPSHER SMITH LABS

FDA Drug Application

Application #077759

Application Sponsors

ANDA 077759UPSHER SMITH LABS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 2.5MG BASE0AMLODIPINE BESYLATEAMLODIPINE BESYLATE
002TABLET;ORALEQ 5MG BASE0AMLODIPINE BESYLATEAMLODIPINE BESYLATE
003TABLET;ORALEQ 10MG BASE0AMLODIPINE BESYLATEAMLODIPINE BESYLATE

FDA Submissions

ORIG1AP2007-07-09
LABELING; LabelingSUPPL5AP2010-04-30
LABELING; LabelingSUPPL7AP2012-01-03
LABELING; LabelingSUPPL8AP2014-09-26STANDARD
LABELING; LabelingSUPPL9AP2015-09-24STANDARD
LABELING; LabelingSUPPL10AP2018-04-26STANDARD

Submissions Property Types

SUPPL5Null7
SUPPL7Null15
SUPPL8Null7
SUPPL9Null7
SUPPL10Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

UPSHER SMITH LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77759
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMLODIPINE BESYLATE","submission":"AMLODIPINE BESYLATE","actionType":"EQ 2.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE","submission":"AMLODIPINE BESYLATE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE","submission":"AMLODIPINE BESYLATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.