Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201355
Company: NOSTRUM LABS INC

Products on ANDA 201355

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITROFURANTOIN	NITROFURANTOIN	25MG/5ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201355

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/2013	ORIG-1	Approval	Not Applicable		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/201355Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2016	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
06/25/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201355

NITROFURANTOIN

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	212607	AUROBINDO PHARMA
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
NITROFURANTOIN	NITROFURANTOIN	25MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	216385	NOVITIUM PHARMA