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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216801
Company: PADAGIS ISRAEL

Products on ANDA 216801

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216801

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

AZELASTINE HYDROCHLORIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 0.2055MG/SPRAY

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ASTEPRO ALLERGY	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	Yes	213872	BAYER HLTHCARE
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	No	216801	PADAGIS ISRAEL
CHILDREN'S ASTEPRO ALLERGY	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	Yes	213872	BAYER HLTHCARE

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