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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201444
Company: HOPE PHARMS

Summary Review

Products on NDA 201444

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITHIODOTE	SODIUM NITRITE; SODIUM THIOSULFATE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201444

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/14/2011	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201444s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201444s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201444_nithiodote_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201444Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2021	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201444s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201444Orig1s026ltr.pdf
10/19/2017	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201444s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201444Orig1s019ltr.pdf
04/22/2016	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
06/14/2016	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
02/03/2015	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
01/26/2015	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/24/2014	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/03/2014	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/14/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/08/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/28/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 201444

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2021	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201444s026lbl.pdf
10/19/2017	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201444s019lbl.pdf
01/14/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201444s000lbl.pdf

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