Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077704
Company: HI TECH PHARMA CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUNISOLIDE FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED;NASAL 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
08/03/2006 ORIG-1 Approval

Label is not available on this site.

FLUNISOLIDE

SPRAY, METERED;NASAL; 0.025MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUNISOLIDE FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 074805 BAUSCH AND LOMB
FLUNISOLIDE FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 077704 HI TECH PHARMA CO

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