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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203922
Company: HOPE PHARMS

Summary Review

Products on NDA 203922

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM NITRITE	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203922

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/14/2012	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203922s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203922s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203922_sodium_nitrite_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203922Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2021	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203922s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203922Orig1s003ltr.pdf
10/19/2017	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203922s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203922Orig1s001ltr.pdf

Labels for NDA 203922

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203922s003lbl.pdf
10/19/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203922s001lbl.pdf
02/14/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203922s000lbl.pdf

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