ANDA 078654

SUN PHARM INDS INC

FDA Drug Application

Application #078654

Application Sponsors

ANDA 078654

SUN PHARM INDS INC

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

	ORIG	1	AP	2014-08-27
LABELING; Labeling	SUPPL	3	AP	2021-01-21	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-02-05	STANDARD
LABELING; Labeling	SUPPL	10	AP	2023-01-17	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	3	Null	7
SUPPL	8	Null	7
SUPPL	10	Null	7

TE Codes

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

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78654
            [companyName] => SUN PHARM INDS INC
            [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":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"0.125MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"0.25MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"0.5MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"1MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"2MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)