ANDA 205663

UNIQUE PHARM LABS

FDA Drug Application

Application #205663

Application Sponsors

ANDA 205663

UNIQUE PHARM LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

450MG

0

LITHIUM CARBONATE

LITHIUM CARBONATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-06-05	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-12-20	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-02-28	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-10-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	5	Null	15
SUPPL	9	Null	7

TE Codes

001

Prescription

AB

CDER Filings

UNIQUE PHARM LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205663
            [companyName] => UNIQUE PHARM LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LITHIUM CARBONATE","activeIngredients":"LITHIUM CARBONATE","strength":"450MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/05\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/28\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/20\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/07\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-28
        )

)