Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207610
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/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
05/17/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

AZELASTINE HYDROCHLORIDE

SPRAY, METERED;NASAL; 0.137MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ASTELIN AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 020114 MYLAN SPECIALITY LP
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 207610 AKORN
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 208156 ALKEM LABS LTD
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 204660 AMNEAL
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 077954 APOTEX INC
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 212289 AUROBINDO PHARMA LTD
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 090176 BRECKENRIDGE
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 091444 HIKMA PHARMS
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 090423 SUN PHARM
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 202609 UPSHER SMITH LABS
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 091409 ZYDUS PHARMS

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