Application 203460
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | MIDAZOLAM HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML | No | No |
| 002 | MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | MIDAZOLAM HYDROCHLORIDE | 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 |
|---|
| 76045-001 | Midazolam | Midazolam Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-001 | Midazolam | Midazolam Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-001 | Midazolam | Midazolam Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-001 | Midazolam | Midazolam Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-002 | Midazolam | Midazolam Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-002 | Midazolam | Midazolam Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-002 | Midazolam | Midazolam Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-002 | Midazolam | Midazolam Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-003 | Midazolam | Midazolam Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-003 | Midazolam | Midazolam Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-003 | Midazolam | Midazolam Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-003 | Midazolam | Midazolam Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-211 | Midazolam | Midazolam Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |