Application 214507
- Type
- ANDA
- Sponsor
- HONG KONG
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | INJECTABLE;INJECTION | EQ 50MG BASE/ML | No | No |
| 002 | HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | INJECTABLE;INJECTION | EQ 100MG BASE/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71288-502 | Haloperidol Decanoate | Haloperidol Decanoate | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-503 | Haloperidol Decanoate | Haloperidol Decanoate | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-504 | Haloperidol Decanoate | Haloperidol Decanoate | Meitheal Pharmaceuticals Inc. | ANDA | Current |