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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208156
Company: ALKEM LABS LTD
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
08/18/2017 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
04/30/2021 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

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
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
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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