Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207712
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE EQ 0.125MG BASE/SPRAY;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
04/28/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL; EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 207712 APOTEX INC
DYMISTA AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 202236 MYLAN SPECIALITY LP

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