ANDA 206868

INVAGEN PHARMS

FDA Drug Application

Application #206868

Application Sponsors

ANDA 206868

INVAGEN PHARMS

Marketing Status

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

Application Products

001	TABLET, CHEWABLE;ORAL	EQ 500MG BASE	0	LANTHANUM CARBONATE	LANTHANUM CARBONATE
002	TABLET, CHEWABLE;ORAL	EQ 750MG BASE	0	LANTHANUM CARBONATE	LANTHANUM CARBONATE
003	TABLET, CHEWABLE;ORAL	EQ 1GM BASE	0	LANTHANUM CARBONATE	LANTHANUM CARBONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-01-24

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206868
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANTHANUM CARBONATE","activeIngredients":"LANTHANUM CARBONATE","strength":"EQ 500MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LANTHANUM CARBONATE","activeIngredients":"LANTHANUM CARBONATE","strength":"EQ 750MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LANTHANUM CARBONATE","activeIngredients":"LANTHANUM CARBONATE","strength":"EQ 1GM BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LANTHANUM CARBONATE","submission":"LANTHANUM CARBONATE","actionType":"EQ 500MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LANTHANUM CARBONATE","submission":"LANTHANUM CARBONATE","actionType":"EQ 750MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LANTHANUM CARBONATE","submission":"LANTHANUM CARBONATE","actionType":"EQ 1GM BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)