Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091409
Company: ZYDUS PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/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
08/14/2017 ORIG-1 Approval

Label is not available on this site.

AZELASTINE HYDROCHLORIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ASTELIN AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 020114 MYLAN SPECIALITY LP
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 208156 ALKEM LABS LTD
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 204660 AMNEAL PHARMS LLC
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 077954 APOTEX INC
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 090176 BRECKENRIDGE PHARM
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 090423 SUN PHARMA GLOBAL
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 202609 UPSHER-SMITH LABS
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 091444 WEST-WARD PHARMS INT
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 091409 ZYDUS PHARMS USA INC

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