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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021780
Company: EVUS

Products on NDA 021780

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITROMIST	NITROGLYCERIN	0.4MG/SPRAY	AEROSOL, METERED;SUBLINGUAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021780

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/02/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021780s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021780_nitromist_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/24/2022	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021780s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021780Orig1s008ltr.pdf
06/10/2016	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021780s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021780Orig1s007ltr.pdf
03/08/2011	SUPPL-3	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021780s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021780s003ltr.pdf

Labels for NDA 021780

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/24/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021780s008lbl.pdf
06/10/2016	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021780s007lbl.pdf
03/08/2011	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021780s003lbl.pdf

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