Application 074893
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-469 | Haloperidol Decanoate | HALOPERIDOL DECANOATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-469 | Haloperidol Decanoate | HALOPERIDOL DECANOATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-469 | Haloperidol Decanoate | HALOPERIDOL DECANOATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-469 | Haloperidol Decanoate | HALOPERIDOL DECANOATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-471 | Haloperidol Decanoate | HALOPERIDOL DECANOATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-471 | Haloperidol Decanoate | HALOPERIDOL DECANOATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-471 | Haloperidol Decanoate | HALOPERIDOL DECANOATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-471 | Haloperidol Decanoate | HALOPERIDOL DECANOATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-471 | Haloperidol Decanoate | HALOPERIDOL DECANOATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-471 | Haloperidol Decanoate | HALOPERIDOL DECANOATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 64725-0471 | Haloperidol Decanoate | HALOPERIDOL DECANOATE | TYA Pharmaceuticals | ANDA | Current |