ANDA 203433

HIKMA

FDA Drug Application

Application #203433

Documents

• Review: 2021-09-24

Application Sponsors

ANDA 203433

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER;INHALATION	0.1MG/INH;EQ 0.05MG BASE/INH	0	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
002	POWDER;INHALATION	0.25MG/INH;EQ 0.05MG BASE/INH	0	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-12-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2021-09-20	UNKNOWN

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203433
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE","activeIngredients":"FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE","strength":"0.1MG\/INH;EQ 0.05MG BASE\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE","activeIngredients":"FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE","strength":"0.25MG\/INH;EQ 0.05MG BASE\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-17
        )

)