ANDA 202805

SANDOZ INC

FDA Drug Application

Application #202805

Application Sponsors

ANDA 202805

SANDOZ INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	125MG	0	GRISEOFULVIN, ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE
002	TABLET;ORAL	250MG	0	GRISEOFULVIN, ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-12-26

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202805
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GRISEOFULVIN, ULTRAMICROSIZE","activeIngredients":"GRISEOFULVIN, ULTRAMICROSIZE","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GRISEOFULVIN, ULTRAMICROSIZE","activeIngredients":"GRISEOFULVIN, ULTRAMICROSIZE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-26
        )

)