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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207921
Company: NORTON WATERFORD

Products on NDA 207921

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QVAR REDIHALER	BECLOMETHASONE DIPROPIONATE	0.04MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	No
QVAR REDIHALER	BECLOMETHASONE DIPROPIONATE	0.08MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207921

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207921s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207921Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207921Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/06/2021	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207921Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207921Orig1s004ltr.pdf
11/19/2018	SUPPL-3	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207921Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/207921Orig1s003ltr.pdf

Labels for NDA 207921

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/06/2021	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207921Orig1s004lbl.pdf
01/06/2021	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207921Orig1s004lbl.pdf
11/19/2018	SUPPL-3	Tentative Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207921Orig1s003lbl.pdf
08/03/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207921s000lbl.pdf

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