NDA 018264

PAR STERILE PRODUCTS

FDA Drug Application

Application #018264

Documents

• Label: 2008-11-07
• Letter: 2008-10-27

Application Sponsors

NDA 018264

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG/VIAL

1

DANTRIUM

DANTROLENE SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1979-09-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1980-06-16	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	1982-02-26
LABELING; Labeling	SUPPL	4	AP	1981-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1981-05-30	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1981-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-02-12	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1987-05-12
LABELING; Labeling	SUPPL	9	AP	1986-02-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-08-06	PRIORITY
EFFICACY; Efficacy	SUPPL	11	AP	1987-05-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1985-08-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1987-06-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1987-12-11	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1989-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1988-06-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1989-02-21	PRIORITY
LABELING; Labeling	SUPPL	19	AP	2000-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-07-12	PRIORITY
LABELING; Labeling	SUPPL	22	AP	2001-10-01	STANDARD
LABELING; Labeling	SUPPL	25	AP	2008-10-09	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	5	Null	14
SUPPL	7	Null	14
SUPPL	10	Null	14
SUPPL	12	Null	14
SUPPL	13	Null	14
SUPPL	14	Null	14
SUPPL	16	Null	14
SUPPL	17	Null	14
SUPPL	21	Null	14

TE Codes

001

Prescription

AP

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18264
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DANTRIUM","activeIngredients":"DANTROLENE SODIUM","strength":"20MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/09\/2008","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018264s025lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DANTRIUM","submission":"DANTROLENE SODIUM","actionType":"20MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2008-10-09
        )

)