ANDA 211542

ALEMBIC PHARMS LTD

FDA Drug Application

Application #211542

Application Sponsors

ANDA 211542

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	7.5MG	0	TEMAZEPAM	TEMAZEPAM
002	CAPSULE;ORAL	15MG	0	TEMAZEPAM	TEMAZEPAM
003	CAPSULE;ORAL	22.5MG	0	TEMAZEPAM	TEMAZEPAM
004	CAPSULE;ORAL	30MG	0	TEMAZEPAM	TEMAZEPAM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-11-23	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-06-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	8	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211542
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEMAZEPAM","activeIngredients":"TEMAZEPAM","strength":"7.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMAZEPAM","activeIngredients":"TEMAZEPAM","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMAZEPAM","activeIngredients":"TEMAZEPAM","strength":"22.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMAZEPAM","activeIngredients":"TEMAZEPAM","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-23
        )

)