Application 075305
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | INJECTABLE;INJECTION | EQ 100MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0143-9295 | Haloperidol Decanoate | Haloperidol Decanoate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9295 | Haloperidol Decanoate | Haloperidol Decanoate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9296 | Haloperidol Decanoate | Haloperidol Decanoate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9296 | Haloperidol Decanoate | Haloperidol Decanoate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 42976 | ORIG | 1998-09-28 |
| 30842 | ORIG | 1998-09-28 |