Application 076774
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HALOPERIDOL | HALOPERIDOL LACTATE | INJECTABLE;INJECTION | EQ 5MG BASE/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51991-933 | Haloperidol | Haloperidol Lactate | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 68083-117 | Haloperidol | Haloperidol | Gland Pharma Limited | ANDA | Current |
| 68083-117 | Haloperidol | Haloperidol | Gland Pharma Limited | ANDA | Current |
| 68083-117 | Haloperidol | Haloperidol | Gland Pharma Limited | ANDA | Current |