ANDA 212579

LAURUS LABS LTD

FDA Drug Application

Application #212579

Application Sponsors

ANDA 212579

LAURUS LABS LTD

Marketing Status

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

Application Products

001	CAPSULE;ORAL	EQ 150MG BASE	0	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE
002	CAPSULE;ORAL	EQ 200MG BASE	0	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE
003	CAPSULE;ORAL	EQ 300MG BASE	0	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-04-30

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

LAURUS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212579
            [companyName] => LAURUS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATAZANAVIR SULFATE","activeIngredients":"ATAZANAVIR SULFATE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATAZANAVIR SULFATE","activeIngredients":"ATAZANAVIR SULFATE","strength":"EQ 200MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATAZANAVIR SULFATE","activeIngredients":"ATAZANAVIR SULFATE","strength":"EQ 300MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATAZANAVIR SULFATE","submission":"ATAZANAVIR SULFATE","actionType":"EQ 150MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATAZANAVIR SULFATE","submission":"ATAZANAVIR SULFATE","actionType":"EQ 200MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATAZANAVIR SULFATE","submission":"ATAZANAVIR SULFATE","actionType":"EQ 300MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)