ANDA 216594

UMEDICA LABS PVT LTD

FDA Drug Application

Application #216594

Application Sponsors

ANDA 216594

UMEDICA LABS PVT LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	100MG	0	CARBAMAZEPINE	CARBAMAZEPINE
002	TABLET, EXTENDED RELEASE;ORAL	200MG	0	CARBAMAZEPINE	CARBAMAZEPINE
003	TABLET, EXTENDED RELEASE;ORAL	400MG	0	CARBAMAZEPINE	CARBAMAZEPINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

UMEDICA LABS PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216594
            [companyName] => UMEDICA LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"400MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-18
        )

)