Application 078405
- Type
- NDA
- Sponsor
- SUN PHARMA GLOBAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47335-882 | nicardipine hydrochloride | nicardipine hydrochloride | Sun Pharmaceutical Industries, Inc. | NDA | Current |