ANDA 211823

ALEMBIC PHARMS LTD

FDA Drug Application

Application #211823

Application Sponsors

ANDA 211823

ALEMBIC PHARMS LTD

Marketing Status

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

Application Products

001	CAPSULE;ORAL	EQ 30MG BASE	0	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE
002	CAPSULE;ORAL	EQ 45MG BASE	0	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE
003	CAPSULE;ORAL	EQ 75MG BASE	0	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211823
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 30MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 45MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/24\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-24
        )

)