ANDA 091656

CADILA PHARMS LTD

FDA Drug Application

Application #091656

Application Sponsors

ANDA 091656

CADILA PHARMS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	200MG	0	OFLOXACIN	OFLOXACIN
002	TABLET;ORAL	300MG	0	OFLOXACIN	OFLOXACIN
003	TABLET;ORAL	400MG	0	OFLOXACIN	OFLOXACIN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-09-18
LABELING; Labeling	SUPPL	2	AP	2016-07-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-10-16	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	2	Null	15
SUPPL	4	Null	31
SUPPL	5	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

CADILA PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91656
            [companyName] => CADILA PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OFLOXACIN","activeIngredients":"OFLOXACIN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OFLOXACIN","activeIngredients":"OFLOXACIN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OFLOXACIN","activeIngredients":"OFLOXACIN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OFLOXACIN","submission":"OFLOXACIN","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OFLOXACIN","submission":"OFLOXACIN","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OFLOXACIN","submission":"OFLOXACIN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)