ANDA 210441

APPCO

FDA Drug Application

Application #210441

Documents

• Label: 2020-04-08
• Letter: 2020-04-08

Application Sponsors

ANDA 210441

APPCO

Marketing Status

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

Application Products

001	TABLET;ORAL	200MG	0	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE
002	TABLET;ORAL	100MG	0	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE
003	TABLET;ORAL	300MG	0	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE
004	TABLET;ORAL	400MG	0	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-05-01	STANDARD
LABELING; Labeling	SUPPL	8	AP	2022-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2022-09-19	UNKNOWN
LABELING; Labeling	SUPPL	12	AP	2022-07-07	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	8	Null	15
SUPPL	10	Null	15
SUPPL	12	Null	7

TE Codes

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

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210441
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYCHLOROQUINE SULFATE","activeIngredients":"HYDROXYCHLOROQUINE SULFATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/01\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210441Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/01\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210441Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210441Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-05-01
        )

)