Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215700
Company: INFORLIFE
Company: INFORLIFE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | EQ 16MG BASE/250ML (EQ 64MCG BASE/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 |
|---|---|---|---|---|---|---|---|
| 09/15/2022 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215700s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215700Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/215700Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/27/2023 | SUPPL-2 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215700s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215700Orig1s002ltr.pdf | |
| 02/06/2023 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215700s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215700Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/27/2023 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215700s002lbl.pdf | |
| 02/06/2023 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215700s001lbl.pdf | |
| 09/15/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215700s000lbl.pdf |