NDA 018810

THEPHARMANETWORK LLC

FDA Drug Application

Application #018810

Application Sponsors

NDA 018810

THEPHARMANETWORK LLC

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1%

0

THERMAZENE

SILVER SULFADIAZINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1985-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-11-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-11-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-01-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1989-10-24	STANDARD
LABELING; Labeling	SUPPL	8	AP	1990-05-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-08-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2012-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2016-08-11	N/A

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	19	Null	0

TE Codes

001

Prescription

AB

CDER Filings

THEPHARMANETWORK LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18810
            [companyName] => THEPHARMANETWORK LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THERMAZENE","activeIngredients":"SILVER SULFADIAZINE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THERMAZENE","submission":"SILVER SULFADIAZINE","actionType":"1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)