Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009175
Company: CASPER PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FURADANTIN NITROFURANTOIN 25MG/5ML SUSPENSION;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/23/1953 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/11/2016 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

11/03/2014 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

10/14/2010 SUPPL-39 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009175s039ltr.pdf
10/27/2010 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009175s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009175s038ltr.pdf
02/06/2009 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009175s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009175s037ltr.pdf
11/04/2013 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/009175s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/009175Orig1s036ltr.pdf
05/30/2008 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/009175s033ltr.pdf
08/25/1999 SUPPL-26 Labeling

Label is not available on this site.

12/03/1998 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/15/1996 SUPPL-24 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/27/1997 SUPPL-23 Labeling

Label is not available on this site.

04/07/1998 SUPPL-22 Labeling

Label is not available on this site.

08/09/1993 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1999 SUPPL-20 Labeling

Label is not available on this site.

05/13/1988 SUPPL-19 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008693s025_009175s019_016620s045_MacrodantinTOC.cfm
06/12/1987 SUPPL-16 Labeling

Label is not available on this site.

05/18/1993 SUPPL-15 Efficacy-New Indication

Label is not available on this site.

11/18/1982 SUPPL-13 Labeling

Label is not available on this site.

06/12/1987 SUPPL-12 Labeling

Label is not available on this site.

12/17/1979 SUPPL-11 Labeling

Label is not available on this site.

04/25/1980 SUPPL-10 Labeling

Label is not available on this site.

01/03/1978 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/23/1973 SUPPL-6

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/04/2013 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/009175s036lbl.pdf
10/27/2010 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009175s038lbl.pdf
02/06/2009 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009175s037lbl.pdf

FURADANTIN

SUSPENSION;ORAL; 25MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FURADANTIN NITROFURANTOIN 25MG/5ML SUSPENSION;ORAL Prescription Yes AB 009175 CASPER PHARMA LLC
NITROFURANTOIN NITROFURANTOIN 25MG/5ML SUSPENSION;ORAL Prescription No AB 205180 ACTAVIS MID ATLANTIC
NITROFURANTOIN NITROFURANTOIN 25MG/5ML SUSPENSION;ORAL Prescription No AB 201679 AMNEAL PHARMS
NITROFURANTOIN NITROFURANTOIN 25MG/5ML SUSPENSION;ORAL Prescription No AB 201355 NOSTRUM LABS INC
NITROFURANTOIN NITROFURANTOIN 25MG/5ML SUSPENSION;ORAL Prescription No AB 201693 NOVEL LABS INC

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