Application 213536
- Type
- NDA
- Sponsor
- SINTETICA, SA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | REZIPRES | EPHEDRINE HYDROCHLORIDE | INJECTABLE;INJECTION | 4.7MG/ML | No | No |
| 002 | REZIPRES | EPHEDRINE HYDROCHLORIDE | INJECTABLE;INJECTION | 9.4MG/ML | No | No |
| 003 | REZIPRES | EPHEDRINE HYDROCHLORIDE | INJECTABLE;INJECTION | 47MG/ML | No | No |
| 004 | REZIPRES | EPHEDRINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 47MG/10ML (4.7MG/ML) | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 39822-1410 | REZIPRES | Ephedrine hydrochloride | XGen Pharmaceuticals DJB, Inc. | NDA | Current |
| 71863-210 | REZIPRES | Ephedrine hydrochloride | Eton Pharmaceuticals, Inc. | NDA | Current |
| 71863-210 | REZIPRES | Ephedrine hydrochloride | Eton Pharmaceuticals, Inc. | NDA | Current |
| 71863-211 | REZIPRES | Ephedrine hydrochloride | Eton Pharmaceuticals, Inc. | NDA | Current |
| 71863-211 | REZIPRES | Ephedrine hydrochloride | Eton Pharmaceuticals, Inc. | NDA | Current |
| 71863-212 | REZIPRES | Ephedrine hydrochloride | Eton Pharmaceuticals, Inc. | NDA | Current |
| 71863-212 | REZIPRES | Ephedrine hydrochloride | Eton Pharmaceuticals, Inc. | NDA | Current |