ANDA 091592

SANDOZ INC

FDA Drug Application

Application #091592

Application Sponsors

ANDA 091592

SANDOZ INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	250MG	0	GRISEOFULVIN	GRISEOFULVIN, MICROSIZE
002	TABLET;ORAL	500MG	0	GRISEOFULVIN	GRISEOFULVIN, MICROSIZE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2013-08-07

Submissions Property Types

ORIG

1

Null

7

TE Codes

002

Prescription

AB

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91592
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GRISEOFULVIN","activeIngredients":"GRISEOFULVIN, MICROSIZE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"GRISEOFULVIN","activeIngredients":"GRISEOFULVIN, MICROSIZE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GRISEOFULVIN","submission":"GRISEOFULVIN, MICROSIZE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GRISEOFULVIN","submission":"GRISEOFULVIN, MICROSIZE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)