Drugs@FDA: FDA Approved Drug Products

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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