Application 202648
- Type
- ANDA
- Sponsor
- YUNG SHIN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | No | No |
| 002 | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63126-332 | Granisetron Hydrochloride | Granisetron Hydrochloride | Yung Shin Pharmaceutical Inc. Co., Ltd. | ANDA | Current |
| 63126-333 | Granisetron Hydrochloride | Granisetron Hydrochloride | Yung Shin Pharmaceutical Inc. Co., Ltd. | ANDA | Current |