ANDA 209717

AMNEAL

FDA Drug Application

Application #209717

Application Sponsors

ANDA 209717

AMNEAL

Marketing Status

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

Application Products

001	CAPSULE;ORAL	EQ 100MG BASE	0	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE
002	CAPSULE;ORAL	EQ 150MG BASE	0	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE
003	CAPSULE;ORAL	EQ 200MG BASE	0	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE
004	CAPSULE;ORAL	EQ 300MG BASE	0	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-06-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209717
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATAZANAVIR SULFATE","activeIngredients":"ATAZANAVIR SULFATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"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":"06\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-01
        )

)