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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217438
Company: APOTEX

Products on ANDA 217438

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOMETASONE FUROATE	MOMETASONE FUROATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217438

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

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

MOMETASONE FUROATE

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; 0.05MG/SPRAY

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
MOMETASONE FUROATE	MOMETASONE FUROATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	No	217438	APOTEX
NASONEX 24HR ALLERGY	MOMETASONE FUROATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	Yes	215712	PERRIGO PHARMA INTL

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