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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209379
Company: AM REGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SELENIOUS ACID SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
SELENIOUS ACID SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
SELENIOUS ACID SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/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
04/30/2019 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209379s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209379Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209379Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2021 SUPPL-5 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209379s005lbl.pdf
10/21/2020 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209379s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209379Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/25/2021 SUPPL-5 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209379s005lbl.pdf
10/21/2020 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209379s003lbl.pdf
04/30/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209379s000lbl.pdf
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