Application 075689
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
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 |
|---|
| 51662-1524 | HALOPERIDOL | Haloperidol Lactate | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 52584-474 | Haloperidol | Haloperidol Lactate | General Injectables and Vaccines, Inc | ANDA | Current |
| 55154-9553 | Haloperidol | HALOPERIDOL LACTATE | Cardinal Health | ANDA | Current |
| 55154-9553 | Haloperidol | HALOPERIDOL LACTATE | Cardinal Health 107, LLC | ANDA | Current |
| 55154-9553 | Haloperidol | HALOPERIDOL LACTATE | Cardinal Health | ANDA | Current |
| 63323-474 | Haloperidol | HALOPERIDOL LACTATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-474 | Haloperidol | HALOPERIDOL LACTATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-474 | Haloperidol | HALOPERIDOL LACTATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-474 | Haloperidol | HALOPERIDOL LACTATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 70518-0035 | Haloperidol | HALOPERIDOL LACTATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0035 | Haloperidol | HALOPERIDOL LACTATE | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 30989 | ORIG | 2001-03-09 |