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Approved Drug Products containing Nitrofurantoin listed in the FDA Orange Book. Original Data : FDA Website

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ACTAVIS LABS FL INC

ACTAVIS MID ATLANTIC

ALVOGEN MALTA

AMNEAL PHARMS

CASPER PHARMA LLC

ELKINS SINN

IMPAX LABS INC

IVAX SUB TEVA PHARMS

LANNETT

MYLAN

NOSTRUM LABS INC

NOVEL LABS INC

PROCTER AND GAMBLE

RANBAXY LABS LTD

SANDOZ

SUN PHARM INDUSTRIES

WATSON LABS

WATSON LABS INC

WHITEWORTH TOWN PLSN

ZYDUS PHARMS USA INC

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CAPSULE;ORAL

SUSPENSION;ORAL

TABLET;ORAL

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DISCN

RX

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FURADANTIN

FURALAN

MACROBID

MACRODANTIN

NITROFURANTOIN

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

NITROFURANTOIN MACROCRYSTALLINE

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No

Yes

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

1988-06-24

Application Number

70249

Brand Name

NITROFURANTOIN MACROCR...

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

50MG

Approval Date

1992-12-31

Application Number

73696

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

TABLET;ORAL

Dosage Strength

50MG

Approval Date

1982-01-01

Application Number

80447

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

2015-06-18

Application Number

91095

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

50MG

Approval Date

1982-01-01

Application Number

84326

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

SUSPENSION;ORAL

Dosage Strength

25MG/5ML

Approval Date

2016-05-03

Application Number

205180

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

TABLET;ORAL

Dosage Strength

100MG

Approval Date

1982-01-01

Application Number

85796

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

25MG

Approval Date

2015-06-18

Application Number

91095

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

50MG

Approval Date

1988-06-24

Application Number

70248

Brand Name

NITROFURANTOIN MACROCR...

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

25MG

Approval Date

1992-12-31

Application Number

73696

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

1992-12-31

Application Number

73696

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

50MG

Approval Date

2015-06-18

Application Number

91095

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

TABLET;ORAL

Dosage Strength

100MG

Approval Date

1982-01-01

Application Number

80447

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

75MG;25MG

Approval Date

2015-07-08

Application Number

202250

Brand Name

NITROFURANTOIN (MONOHY...

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

1982-01-01

Application Number

84326

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

TABLET;ORAL

Dosage Strength

50MG

Approval Date

1982-01-01

Application Number

85797

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

1982-01-01

Application Number

16620

Brand Name

MACRODANTIN

RX/OTC/DISCN

RX

RLD

Yes

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

75MG;25MG

Approval Date

1991-12-24

Application Number

20064

Brand Name

MACROBID

RX/OTC/DISCN

RX

RLD

Yes

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

50MG

Approval Date

1982-01-01

Application Number

16620

Brand Name

MACRODANTIN

RX/OTC/DISCN

RX

RLD

Yes

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

25MG

Approval Date

1982-01-01

Application Number

16620

Brand Name

MACRODANTIN

RX/OTC/DISCN

RX

RLD

Yes

TE Code

AB

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Dosage Form Route

SUSPENSION;ORAL

Dosage Strength

25MG/5ML

Approval Date

2011-05-11

Application Number

201679

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

75MG;25MG

Approval Date

2017-05-15

Application Number

207372

Brand Name

NITROFURANTOIN (MONOHY...

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

SUSPENSION;ORAL

Dosage Strength

25MG/5ML

Approval Date

1982-01-01

Application Number

9175

Brand Name

FURADANTIN

RX/OTC/DISCN

RX

RLD

Yes

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

50MG

Approval Date

1993-01-28

Application Number

73671

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

1993-01-28

Application Number

73652

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

TABLET;ORAL

Dosage Strength

50MG

Approval Date

1982-01-01

Application Number

80078

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

TABLET;ORAL

Dosage Strength

100MG

Approval Date

1982-01-01

Application Number

80078

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

TABLET;ORAL

Dosage Strength

100MG

Approval Date

1982-01-01

Application Number

80017

Brand Name

FURALAN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

TABLET;ORAL

Dosage Strength

50MG

Approval Date

1982-01-01

Application Number

80017

Brand Name

FURALAN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

75MG;25MG

Approval Date

2004-03-22

Application Number

76648

Brand Name

NITROFURANTOIN (MONOHY...

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

50MG

Approval Date

1997-07-09

Application Number

74967

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

1997-07-09

Application Number

74967

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

2004-08-18

Application Number

77025

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

SUSPENSION;ORAL

Dosage Strength

25MG/5ML

Approval Date

2013-08-14

Application Number

201355

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

SUSPENSION;ORAL

Dosage Strength

25MG/5ML

Approval Date

2014-09-08

Application Number

201693

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

TABLET;ORAL

Dosage Strength

50MG

Approval Date

1982-01-01

Application Number

8693

Brand Name

FURADANTIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

TABLET;ORAL

Dosage Strength

100MG

Approval Date

1982-01-01

Application Number

8693

Brand Name

FURADANTIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

75MG;25MG

Approval Date

2005-03-30

Application Number

76951

Brand Name

NITROFURANTOIN (MONOHY...

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

50MG

Approval Date

1995-01-25

Application Number

74336

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

75MG;25MG

Approval Date

2005-04-05

Application Number

77066

Brand Name

NITROFURANTOIN (MONOHY...

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

TABLET;ORAL

Dosage Strength

100MG

Approval Date

1982-01-01

Application Number

80043

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

25MG

Approval Date

1995-01-25

Application Number

74336

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

1995-01-25

Application Number

74336

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

TABLET;ORAL

Dosage Strength

50MG

Approval Date

1982-01-01

Application Number

80043

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

25MG

Approval Date

2016-02-16

Application Number

201722

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

2016-02-16

Application Number

201722

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

50MG

Approval Date

2016-02-16

Application Number

201722

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

2017-12-12

Application Number

205005

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

50MG

Approval Date

2017-12-12

Application Number

205005

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

ELKINS SINN

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

TABLET;ORAL

Dosage Strength

100MG

Approval Date

1982-01-01

Application Number

80003

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

Request an Update of Your Company Information, Events & Sales Content

Dosage Form Route

CAPSULE;ORAL

Dosage Strength

50MG

Approval Date

2018-07-09

Application Number

203233

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

75MG;25MG

Approval Date

2018-05-24

Application Number

208516

Brand Name

NITROFURANTOIN (MONOHY...

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

WHITEWORTH TOWN PLSN

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Dosage Form Route

TABLET;ORAL

Dosage Strength

100MG

Approval Date

1982-01-01

Application Number

84085

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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Dosage Form Route

CAPSULE;ORAL

Dosage Strength

100MG

Approval Date

2018-07-09

Application Number

203233

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

RX

RLD

No

TE Code

AB

ELKINS SINN

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Dosage Form Route

TABLET;ORAL

Dosage Strength

50MG

Approval Date

1982-01-01

Application Number

80003

Brand Name

NITROFURANTOIN

RX/OTC/DISCN

DISCN

RLD

No

TE Code

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