Application 214313
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NOREPINEPHRINE BITARTRATE;DEXTROSE | NOREPINEPHRINE BITARTRATE;DEXTROSE | INJECTABLE;INJECTION | 16 MCG/ML | No | No |
| 002 | NOREPINEPHRINE BITARTRATE;DEXTROSE | NOREPINEPHRINE BITARTRATE;DEXTROSE | INJECTABLE;INJECTION | 32 MCG/ML | Yes | No |
| 003 | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | NOREPINEPHRINE BITARTRATE | SOLUTION;INTRAVENOUS | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | Yes | Yes |
| 004 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | SOLUTION;INTRAVENOUS | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | Yes | Yes |
| 005 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | SOLUTION;INTRAVENOUS | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | Yes | Yes |
| 006 | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | SOLUTION;INTRAVENOUS | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0338-0108 | NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0108 | NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0108 | NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0108 | NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0108 | NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0108 | NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0112 | NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0112 | NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0112 | NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0112 | NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0112 | NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0112 | NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | Baxter Healthcare Corporation | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84997 | SUPPL | 2026-02-11 |
| 84970 | SUPPL | 2026-02-09 |
| 80176 | SUPPL | 2024-11-07 |
| 80014 | SUPPL | 2024-10-28 |
| 78981 | SUPPL | 2024-07-05 |
| 71848 | SUPPL | 2022-08-19 |
| 71840 | SUPPL | 2022-08-18 |
| 68094 | ORIG | 2021-07-15 |
| 65935 | ORIG | 2021-01-19 |
| 65914 | ORIG | 2021-01-15 |