NDA 020064

ALVOGEN

FDA Drug Application

Application #020064

Documents

• Letter: 2003-11-05
• Letter: 2007-07-05
• Letter: 2009-03-06
• Letter: 2011-06-09
• Letter: 2003-02-04
• Letter: 2013-09-11
• Label: 2003-11-05
• Label: 2009-03-17
• Label: 2013-09-09
• Letter: 2021-01-22
• Label: 2021-05-25

Application Sponsors

NDA 020064

ALVOGEN

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

75MG;25MG

1

MACROBID

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1991-12-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	1996-02-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-08-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1993-08-23	STANDARD
LABELING; Labeling	SUPPL	5	AP	1998-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-02-13	STANDARD
LABELING; Labeling	SUPPL	7	AP	1997-03-27	STANDARD
LABELING; Labeling	SUPPL	8	AP	1997-07-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	1998-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-11-03	STANDARD
LABELING; Labeling	SUPPL	13	AP	2003-02-04	STANDARD
LABELING; Labeling	SUPPL	14	AP	2003-10-30	STANDARD
LABELING; Labeling	SUPPL	17	AP	2007-06-27	STANDARD
LABELING; Labeling	SUPPL	19	AP	2009-03-05	STANDARD
LABELING; Labeling	SUPPL	20	AP	2011-06-06	STANDARD
LABELING; Labeling	SUPPL	21	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	22	AP	2014-01-07	STANDARD
LABELING; Labeling	SUPPL	29	TA	2020-07-30	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	20	Null	7
SUPPL	21	Null	15
SUPPL	22	Null	0
SUPPL	29	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20064
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"MACROBID","activeIngredients":"NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE","strength":"75MG;25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/06\/2013","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020064s021lbl.pdf\"}]","notes":"Please see"},{"actionDate":"03\/05\/2009","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020064s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2003","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20064slr014_macrobid_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MACROBID","submission":"NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE","actionType":"75MG;25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-09-06
        )

)