Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 214313
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | NOREPINEPHRINE BITARTRATE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | NOREPINEPHRINE BITARTRATE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | 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 |
---|---|---|---|---|---|---|---|
01/15/2021 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214313s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214313Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214313Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/11/2024 | SUPPL-4 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214313Orig1s004Correctedltr.pdf |
06/02/2022 | SUPPL-2 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214313Orig1s002Lbl.pdf | ||
06/02/2022 | SUPPL-1 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214313Orig1s002Ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/02/2022 | SUPPL-2 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214313Orig1s002Lbl.pdf | |
01/15/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214313s000lbl.pdf |