U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207712
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE 0.137MG/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.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/25/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL; 0.137MG/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 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 207712 APOTEX
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 208111 PADAGIS ISRAEL
DYMISTA AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 202236 MYLAN SPECIALITY LP
Back to Top