ANDA 211033

ALEMBIC PHARMS LTD

FDA Drug Application

Application #211033

Application Sponsors

ANDA 211033

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	0.125MG	0	CLONAZEPAM	CLONAZEPAM
002	TABLET, ORALLY DISINTEGRATING;ORAL	0.25MG	0	CLONAZEPAM	CLONAZEPAM
003	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG	0	CLONAZEPAM	CLONAZEPAM
004	TABLET, ORALLY DISINTEGRATING;ORAL	1MG	0	CLONAZEPAM	CLONAZEPAM
005	TABLET, ORALLY DISINTEGRATING;ORAL	2MG	0	CLONAZEPAM	CLONAZEPAM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-06-28	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-02-05	STANDARD
LABELING; Labeling	SUPPL	11	AP	2023-01-17	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7
SUPPL	11	Null	7

TE Codes

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

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211033
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"0.125MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"0.25MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"0.5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"1MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"2MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-28
        )

)