NDA 009175

CASPER PHARMA LLC

FDA Drug Application

Application #009175

Documents

• Letter: 2009-02-13
• Letter: 2010-11-02
• Letter: 2010-10-19
• Letter: 2008-06-03
• Letter: 2013-11-07
• Review: 2006-05-10
• Label: 2013-11-04
• Label: 2009-02-10
• Label: 2016-03-18
• Label: 2019-06-12
• Letter: 2019-06-12
• Label: 2021-01-19
• Letter: 2021-01-19

Application Sponsors

NDA 009175

CASPER PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

25MG/5ML

1

FURADANTIN

NITROFURANTOIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1953-12-23	STANDARD
S; Supplement	SUPPL	6	AP	1973-11-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1978-01-03	STANDARD
LABELING; Labeling	SUPPL	10	AP	1980-04-25
LABELING; Labeling	SUPPL	11	AP	1979-12-17
LABELING; Labeling	SUPPL	12	AP	1987-06-12
LABELING; Labeling	SUPPL	13	AP	1982-11-18
EFFICACY; Efficacy	SUPPL	15	AP	1993-05-18
LABELING; Labeling	SUPPL	16	AP	1987-06-12
LABELING; Labeling	SUPPL	19	AP	1988-05-13
LABELING; Labeling	SUPPL	20	AP	1999-02-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1993-08-09	STANDARD
LABELING; Labeling	SUPPL	22	AP	1998-04-07	STANDARD
LABELING; Labeling	SUPPL	23	AP	1997-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1996-10-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1998-12-03	STANDARD
LABELING; Labeling	SUPPL	26	AP	1999-08-25	STANDARD
LABELING; Labeling	SUPPL	33	AP	2008-05-30	STANDARD
LABELING; Labeling	SUPPL	36	AP	2013-11-04	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	37	AP	2009-02-06	STANDARD
LABELING; Labeling	SUPPL	38	AP	2010-10-27	STANDARD
LABELING; Labeling	SUPPL	39	AP	2010-10-14	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2014-11-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2016-07-11	STANDARD
LABELING; Labeling	SUPPL	46	AP	2019-06-11	STANDARD
LABELING; Labeling	SUPPL	48	AP	2020-12-23	STANDARD

Submissions Property Types

SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	21	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	36	Null	15
SUPPL	38	Null	7
SUPPL	39	Null	6
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	46	Null	7

TE Codes

001

Prescription

AB

CDER Filings

CASPER PHARMA LLC

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(
    [0] => Array
        (
            [ApplNo] => 9175
            [companyName] => CASPER PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FURADANTIN","activeIngredients":"NITROFURANTOIN","strength":"25MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/11\/2019","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/009175s046lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2013","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/009175s036lbl.pdf\"}]","notes":"Please see"},{"actionDate":"10\/27\/2010","submission":"SUPPL-38","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/009175s038lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2009","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/009175s037lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FURADANTIN","submission":"NITROFURANTOIN","actionType":"25MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-06-11
        )

)