Application 215868
- Type
- NDA
- Sponsor
- EXELA PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM | SOLUTION;INTRAVENOUS | 50MG/50ML (1MG/ML) | No | No |
| 002 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM | SOLUTION;INTRAVENOUS | 100MG/100ML (1MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51754-2130 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-2130 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-2131 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-2131 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | Exela Pharma Sciences, LLC | NDA | Current |