Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203922
Company: HOPE PHARMS
Company: HOPE PHARMS
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 |
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 |
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 |