ANDA 076856

IMPAX LABS

FDA Drug Application

Application #076856

Application Sponsors

ANDA 076856

IMPAX LABS

Marketing Status

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

Application Products

001	CAPSULE;ORAL	25MG	0	DANTROLENE SODIUM	DANTROLENE SODIUM
002	CAPSULE;ORAL	50MG	0	DANTROLENE SODIUM	DANTROLENE SODIUM
003	CAPSULE;ORAL	100MG	0	DANTROLENE SODIUM	DANTROLENE SODIUM

FDA Submissions

	ORIG	1	AP	2005-03-01
LABELING; Labeling	SUPPL	8	AP	2015-08-31	STANDARD

Submissions Property Types

SUPPL

8

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76856
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DANTROLENE SODIUM","activeIngredients":"DANTROLENE SODIUM","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DANTROLENE SODIUM","activeIngredients":"DANTROLENE SODIUM","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DANTROLENE SODIUM","activeIngredients":"DANTROLENE SODIUM","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DANTROLENE SODIUM","submission":"DANTROLENE SODIUM","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DANTROLENE SODIUM","submission":"DANTROLENE SODIUM","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DANTROLENE SODIUM","submission":"DANTROLENE SODIUM","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)