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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078492
Company: CHARTWELL RX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/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
01/09/2012 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/14/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL; 0.05MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 077538 APOTEX INC
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 078492 CHARTWELL RX
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 076504 HIKMA
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