Application 216146
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPHEDRINE SULFATE | EPHEDRINE SULFATE | SOLUTION;INTRAVENOUS | 50MG/ML (50MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68083-495 | Ephedrine Sulfate | Ephedrine Sulfate | Gland Pharma Limited | ANDA | Current |