Application 218038
- Type
- NDA
- Sponsor
- HQ SPCLT PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | DILTIAZEM HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 100MG/100ML (1MG/ML) | Yes | Yes |
| 002 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | DILTIAZEM HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 250MG/250ML (1MG/ML) | Yes | Yes |