ANDA 077246

LANNETT CO INC

FDA Drug Application

Application #077246

Application Sponsors

ANDA 077246

LANNETT CO INC

Marketing Status

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

Application Products

001	CAPSULE;ORAL	200MG	0	DANAZOL	DANAZOL
002	CAPSULE;ORAL	50MG	0	DANAZOL	DANAZOL
003	CAPSULE;ORAL	100MG	0	DANAZOL	DANAZOL

FDA Submissions

	ORIG	1	AP	2005-09-28
LABELING; Labeling	SUPPL	4	AP	2007-10-29
LABELING; Labeling	SUPPL	6	AP	2012-03-15
LABELING; Labeling	SUPPL	14	AP	2018-08-22	STANDARD

Submissions Property Types

SUPPL	6	Null	15
SUPPL	14	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77246
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DANAZOL","activeIngredients":"DANAZOL","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DANAZOL","activeIngredients":"DANAZOL","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DANAZOL","activeIngredients":"DANAZOL","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DANAZOL","submission":"DANAZOL","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DANAZOL","submission":"DANAZOL","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DANAZOL","submission":"DANAZOL","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)