Application 214628
- Type
- NDA
- Sponsor
- NEVAKAR INJECTABLES, INC.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION | NOREPINEPHRINE IN SODIUM CHLORIDE | INJECTABLE;INJECTION | EQ 250ML BASE/ | No | No |
| 002 | NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION | NOREPINEPHRINE IN SODIUM CHLORIDE | INJECTABLE;INJECTION | EQ 8MG BASE/250ML | No | No |
| 003 | NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION | NOREPINEPHRINE IN SODIUM CHLORIDE | INJECTABLE;INJECTION | EQ 16MG BASE/250ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42023-245 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE IN SODIUM CHLORIDE | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-246 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE in Sodium Chloride | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-247 | NOREPINEPHRINE BITARTRATE | Norepinephrine in Sodium Chloride | Par Pharmaceutical, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80534 | SUPPL | 2024-12-06 |
| 80533 | SUPPL | 2024-12-06 |
| 75305 | ORIG | 2023-08-28 |
| 72276 | ORIG | 2022-10-07 |