ANDA 202595

NATCO PHARMA LTD

FDA Drug Application

Application #202595

Documents

• Label: 2016-08-22

Application Sponsors

ANDA 202595

NATCO PHARMA 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	2016-08-03
LABELING; Labeling	SUPPL	5	AP	2021-04-09	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-04-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-04-09	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15
SUPPL	9	Null	15
SUPPL	11	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

NATCO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202595
            [companyName] => NATCO PHARMA 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] => [{"actionDate":"08\/03\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202595Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/03\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202595Orig1s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-08-03
        )

)