Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208111
Company: PADAGIS ISRAEL

Products on ANDA 208111

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208111

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/2021	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
06/12/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208111

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