Application 208943
- Type
- NDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CORPHEDRA | EPHEDRINE SULFATE | SOLUTION;INTRAVENOUS | 50MG/ML (50MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42023-196 | Corphedra | Ephedrine Sulfate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-196 | Corphedra | Ephedrine Sulfate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-196 | Corphedra | Ephedrine Sulfate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-216 | Ephedrine Sulfate | Ephedrine Sulfate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-216 | Ephedrine Sulfate | Ephedrine Sulfate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-233 | Corphedra | ephedrine sulfate | Par Pharmaceutical, Inc. | NDA | Current |
| 51662-1325 | EPHEDRINE SULFATE | EPHEDRINE SULFATE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1325 | EPHEDRINE SULFATE | EPHEDRINE SULFATE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1325 | EPHEDRINE SULFATE | EPHEDRINE SULFATE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1325 | EPHEDRINE SULFATE | EPHEDRINE SULFATE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53817 | ORIG | 2018-04-25 |
| 47058 | ORIG | 2017-01-31 |
| 47036 | ORIG | 2017-01-27 |