Application 091137
- Type
- ANDA
- Sponsor
- MYLAN ASI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE; INJECTION | 1MG/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 |
|---|---|---|---|---|---|
| 25021-781 | granisetron hydrochloride | granisetron hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 67457-864 | Granisetron Hydrochloride | Granisetron Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-864 | Granisetron Hydrochloride | Granisetron Hydrochloride | Mylan Institutional LLC | ANDA | Current |