ANDA 210568

ALKEM LABS LTD

FDA Drug Application

Application #210568

Application Sponsors

ANDA 210568

ALKEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 100MG BASE	0	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL
002	TABLET;ORAL	EQ 200MG BASE	0	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210568
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFPODOXIME PROXETIL","activeIngredients":"CEFPODOXIME PROXETIL","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFPODOXIME PROXETIL","activeIngredients":"CEFPODOXIME PROXETIL","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-18
        )

)