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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207989
Company: AMNEAL PHARMS

Products on ANDA 207989

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOMETASONE FUROATE	MOMETASONE FUROATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207989

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/03/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207989

MOMETASONE FUROATE

SPRAY, METERED;NASAL; 0.05MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MOMETASONE FUROATE	MOMETASONE FUROATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	207989	AMNEAL PHARMS
MOMETASONE FUROATE	MOMETASONE FUROATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	091161	APOTEX
MOMETASONE FUROATE	MOMETASONE FUROATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	215878	AUROBINDO PHARMA

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