An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205180
Company: ACTAVIS MID ATLANTIC

Products on ANDA 205180

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 205180

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/03/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 205180

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

Top