Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091161
Company: APOTEX

Products on ANDA 091161

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091161

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2016	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091161Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/27/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/27/2024	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/27/2024	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/27/2024	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091161

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