ANDA 091316

DR REDDYS LABS LTD

FDA Drug Application

Application #091316

Documents

• Letter: 2011-07-28

Application Sponsors

ANDA 091316

DR REDDYS LABS LTD

Marketing Status

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

Application Products

001	INJECTABLE;SUBCUTANEOUS	2.5MG/0.5ML	0	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM
002	INJECTABLE;SUBCUTANEOUS	5MG/0.4ML	0	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM
003	INJECTABLE;SUBCUTANEOUS	7.5MG/0.6ML	0	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM
004	INJECTABLE;SUBCUTANEOUS	10MG/0.8ML	0	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM

FDA Submissions

	ORIG	1	AP	2011-07-11
LABELING; Labeling	SUPPL	2	AP	2014-03-19	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-02-18	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	15
SUPPL	3	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91316
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FONDAPARINUX SODIUM","activeIngredients":"FONDAPARINUX SODIUM","strength":"2.5MG\/0.5ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FONDAPARINUX SODIUM","activeIngredients":"FONDAPARINUX SODIUM","strength":"5MG\/0.4ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FONDAPARINUX SODIUM","activeIngredients":"FONDAPARINUX SODIUM","strength":"7.5MG\/0.6ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FONDAPARINUX SODIUM","activeIngredients":"FONDAPARINUX SODIUM","strength":"10MG\/0.8ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FONDAPARINUX SODIUM","submission":"FONDAPARINUX SODIUM","actionType":"2.5MG\/0.5ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FONDAPARINUX SODIUM","submission":"FONDAPARINUX SODIUM","actionType":"5MG\/0.4ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FONDAPARINUX SODIUM","submission":"FONDAPARINUX SODIUM","actionType":"7.5MG\/0.6ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FONDAPARINUX SODIUM","submission":"FONDAPARINUX SODIUM","actionType":"10MG\/0.8ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)