Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209379
Company: AM REGENT
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 | ||
08/30/2021 | SUPPL-4 | Manufacturing (CMC)-New Strength |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209379s004lbl.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 |
---|---|---|---|---|---|
08/30/2021 | SUPPL-4 | Manufacturing (CMC)-New Strength | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209379s004lbl.pdf | |
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 |