ANDA 076112

DR REDDYS LABS INC

FDA Drug Application

Application #076112

Documents

• Review: 2001-10-31

Application Sponsors

ANDA 076112

DR REDDYS LABS INC

Marketing Status

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

Application Products

001	TABLET;ORAL	400MG	0	IBUPROFEN	IBUPROFEN
002	TABLET;ORAL	600MG	0	IBUPROFEN	IBUPROFEN
003	TABLET;ORAL	800MG	0	IBUPROFEN	IBUPROFEN

FDA Submissions

	ORIG	1	AP	2001-10-31
LABELING; Labeling	SUPPL	9	AP	2006-03-31
LABELING; Labeling	SUPPL	11	AP	2008-12-11
LABELING; Labeling	SUPPL	15	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-07-22	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	15	Null	15
SUPPL	16	Null	7
SUPPL	17	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76112
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)