Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201693
Company: NOVEL LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROFURANTOIN NITROFURANTOIN 25MG/5ML SUSPENSION;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/08/2014 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/24/2016 SUPPL-3 Labeling-Container/Carton Labels

Label is not available on this site.

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 201355 NOSTRUM LABS INC
NITROFURANTOIN NITROFURANTOIN 25MG/5ML SUSPENSION;ORAL Prescription No AB 201693 NOVEL LABS INC

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