NDA 016620

ALVOGEN

FDA Drug Application

Application #016620

Documents

• Letter: 2004-04-07
• Letter: 2009-03-06
• Label: 2013-09-09
• Letter: 2003-02-04
• Letter: 2007-09-25
• Letter: 2011-06-09
• Letter: 2013-09-10
• Review: 2007-07-09
• Review: 2007-07-09
• Review: 2007-07-09
• Review: 2007-02-20
• Review: 2008-02-19
• Review: 2008-02-19
• Review: 2008-08-11
• Review: 2008-07-31
• Label: 2004-04-05
• Label: 2007-09-19
• Label: 2009-03-17
• Review: 2007-07-09
• Review: 2007-07-09
• Review: 2006-05-10
• Review: 2008-02-19
• Review: 2008-02-19
• Review: 2008-02-19
• Review: 2008-08-11
• Review: 2008-08-01
• Letter: 2021-01-22
• Label: 2021-08-20

Application Sponsors

NDA 016620

ALVOGEN

Marketing Status

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

Application Products

001	CAPSULE;ORAL	50MG	1	MACRODANTIN	NITROFURANTOIN, MACROCRYSTALLINE
002	CAPSULE;ORAL	100MG	1	MACRODANTIN	NITROFURANTOIN, MACROCRYSTALLINE
003	CAPSULE;ORAL	25MG	1	MACRODANTIN	NITROFURANTOIN, MACROCRYSTALLINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1970-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1976-07-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1976-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1976-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1976-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1977-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1977-05-13	STANDARD
LABELING; Labeling	SUPPL	23	AP	1978-07-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1979-07-26	STANDARD
LABELING; Labeling	SUPPL	26	AP	1979-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1979-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1980-05-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1980-08-14	STANDARD
LABELING; Labeling	SUPPL	31	AP	1982-10-15
LABELING; Labeling	SUPPL	32	AP	1980-12-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1982-05-13	STANDARD
LABELING; Labeling	SUPPL	36	AP	1993-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1983-06-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1984-07-09	STANDARD
LABELING; Labeling	SUPPL	39	AP	1993-05-19
LABELING; Labeling	SUPPL	45	AP	1988-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1989-01-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1990-09-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1990-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1991-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1992-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1992-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1992-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1992-12-08	STANDARD
LABELING; Labeling	SUPPL	56	AP	1998-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1993-08-09	STANDARD
LABELING; Labeling	SUPPL	58	AP	1998-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1996-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1996-07-30	STANDARD
LABELING; Labeling	SUPPL	61	AP	1997-03-27	STANDARD
LABELING; Labeling	SUPPL	62	AP	1997-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1998-10-21	STANDARD
LABELING; Labeling	SUPPL	64	AP	2003-02-04	STANDARD
LABELING; Labeling	SUPPL	65	AP	2004-03-29	STANDARD
LABELING; Labeling	SUPPL	67	AP	2007-09-14	STANDARD
LABELING; Labeling	SUPPL	68	AP	2009-03-05	STANDARD
LABELING; Labeling	SUPPL	70	AP	2011-06-06	STANDARD
LABELING; Labeling	SUPPL	72	AP	2013-09-06	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	2015-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	2015-10-15	STANDARD
LABELING; Labeling	SUPPL	76	TA	2020-07-30	STANDARD

Submissions Property Types

SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	35	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	47	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	57	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	63	Null	0
SUPPL	65	Null	9
SUPPL	70	Null	7
SUPPL	72	Null	7
SUPPL	73	Null	0
SUPPL	74	Null	0
SUPPL	76	Null	31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16620
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"MACRODANTIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MACRODANTIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"MACRODANTIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"09\/06\/2013","submission":"SUPPL-72","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/016620s072lbl.pdf\"}]","notes":"Please see"},{"actionDate":"03\/05\/2009","submission":"SUPPL-68","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/016620s068lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2007","submission":"SUPPL-67","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/016620s067lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2004","submission":"SUPPL-65","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/16620slr065_mecrodantin_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MACRODANTIN","submission":"NITROFURANTOIN, MACROCRYSTALLINE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MACRODANTIN","submission":"NITROFURANTOIN, MACROCRYSTALLINE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MACRODANTIN","submission":"NITROFURANTOIN, MACROCRYSTALLINE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-09-06
        )

)