Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212289
Company: AUROBINDO PHARMA LTD

Products on ANDA 212289

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212289

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212289

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	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	BIONPHARMA
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	207610	EPIC PHARMA LLC
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