ANDA 076255

DR REDDYS LABS LTD

FDA Drug Application

Application #076255

Application Sponsors

ANDA 076255

DR REDDYS LABS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	2.5MG	0	OLANZAPINE	OLANZAPINE
002	TABLET;ORAL	5MG	0	OLANZAPINE	OLANZAPINE
003	TABLET;ORAL	7.5MG	0	OLANZAPINE	OLANZAPINE
004	TABLET;ORAL	10MG	0	OLANZAPINE	OLANZAPINE

FDA Submissions

	ORIG	1	AP	2012-04-23
LABELING; Labeling	SUPPL	2	AP	2015-01-20	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-01-20	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-11-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	7	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	7

TE Codes

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

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76255
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)