Application 019034
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DILAUDID-HP | HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | Yes | No |
| 002 | DILAUDID-HP | HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 250MG/VIAL | No | No |
| 003 | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | Yes | Yes |
| 004 | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 2MG/ML | Yes | Yes |
| 005 | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 4MG/ML | Yes | No |
| 006 | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.2MG/ML | Yes | Yes |
| 007 | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.5MG/0.5ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59011-442 | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | Purdue Pharma LP | NDA | Current |
| 59011-444 | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | Purdue Pharma LP | NDA | Current |
| 63323-851 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-851 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-851 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-852 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-852 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-852 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-853 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-853 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-853 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-854 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-854 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-854 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-009 | Dilaudid | Hydromorphone hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-009 | Dilaudid | Hydromorphone hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-009 | Dilaudid | Hydromorphone hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-009 | Dilaudid | Hydromorphone hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-009 | Dilaudid | Hydromorphone hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-010 | Dilaudid | Hydromorphone hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-010 | Dilaudid | Hydromorphone hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-010 | Dilaudid | Hydromorphone hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-010 | Dilaudid | Hydromorphone hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-010 | Dilaudid | Hydromorphone hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-121 | Dilaudid | Hydromorphone hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-121 | Dilaudid | Hydromorphone hydrochloride | Fresenius Kabi USA, LLC | NDA | Current |