ANDA 206432

CADILA PHARMS LTD

FDA Drug Application

Application #206432

Application Sponsors

ANDA 206432

CADILA PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	60MG	0	NATEGLINIDE	NATEGLINIDE
002	TABLET;ORAL	120MG	0	NATEGLINIDE	NATEGLINIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-04-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2023-01-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CADILA PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206432
            [companyName] => CADILA PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NATEGLINIDE","activeIngredients":"NATEGLINIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NATEGLINIDE","activeIngredients":"NATEGLINIDE","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-19
        )

)