ANDA 065356

SUN PHARM INDS LTD

FDA Drug Application

Application #065356

Application Sponsors

ANDA 065356

SUN PHARM INDS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 50MG BASE	0	DOXYCYCLINE	DOXYCYCLINE
002	TABLET;ORAL	EQ 75MG BASE	0	DOXYCYCLINE	DOXYCYCLINE
003	TABLET;ORAL	EQ 100MG BASE	0	DOXYCYCLINE	DOXYCYCLINE
004	TABLET;ORAL	EQ 150MG BASE	0	DOXYCYCLINE	DOXYCYCLINE

FDA Submissions

	ORIG	1	AP	2006-05-31
LABELING; Labeling	SUPPL	3	AP	2010-07-29
LABELING; Labeling	SUPPL	8	AP	2010-12-13
LABELING; Labeling	SUPPL	10	AP	2015-01-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-06-22	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-06-22	STANDARD
LABELING; Labeling	SUPPL	15	AP	2022-06-22	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	3	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	13	Null	7
SUPPL	15	Null	7

TE Codes

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

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65356
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOXYCYCLINE","submission":"DOXYCYCLINE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXYCYCLINE","submission":"DOXYCYCLINE","actionType":"EQ 75MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXYCYCLINE","submission":"DOXYCYCLINE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXYCYCLINE","submission":"DOXYCYCLINE","actionType":"EQ 150MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)