Application 075858
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0143-9319 | Haloperidol | Haloperidol lactate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9319 | Haloperidol | Haloperidol lactate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9319 | Haloperidol | Haloperidol lactate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9501 | Haloperidol | Haloperidol lactate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9501 | Haloperidol | Haloperidol lactate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9501 | Haloperidol | Haloperidol lactate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9502 | Haloperidol | Haloperidol Lactate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9502 | Haloperidol | Haloperidol Lactate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9502 | Haloperidol | Haloperidol Lactate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 55154-7478 | Haloperidol | Haloperidol lactate | Cardinal Health | ANDA | Current |
| 70518-0776 | Haloperidol | Haloperidol lactate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0776 | Haloperidol | Haloperidol lactate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0776 | Haloperidol | Haloperidol lactate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0776 | Haloperidol | Haloperidol lactate | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8812 | ORIG | 2001-06-18 |