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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215712
Company: PERRIGO PHARMA INTL

Products on NDA 215712

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NASONEX 24HR ALLERGY	MOMETASONE FUROATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215712

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2022	ORIG-1	Approval	Type 8 - Partial Rx to OTC Switch	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215712Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215712Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2023	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215712Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215712orig1s015ltr.pdf
03/09/2023	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215712Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215712Orig1s012ltr.pdf
09/19/2022	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215712Orig1s011ltr.pdf
09/20/2022	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215712Orig1s008ltr.pdf
09/20/2022	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215712Orig1s007ltr.pdf
07/15/2022	SUPPL-6	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215712Orig1s006ltr.pdf
09/16/2022	SUPPL-5	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215712Orig1s005ltr.pdf
07/15/2022	SUPPL-4	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215712Orig1s004ltr.pdf

Labels for NDA 215712

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2023	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215712Orig1s015lbl.pdf
03/09/2023	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215712Orig1s012lbl.pdf
09/20/2022	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s008lbl.pdf
09/20/2022	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s007lbl.pdf
09/19/2022	SUPPL-11	Tentative Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s011lbl.pdf
09/16/2022	SUPPL-5	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s005lbl.pdf
07/15/2022	SUPPL-6	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s006lbl.pdf
07/15/2022	SUPPL-4	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s004lbl.pdf
03/17/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215712Orig1s000lbl.pdf

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

NASONEX 24HR ALLERGY

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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