Application 075154
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5MG BASE/ML | No | No |
| 002 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0404-9912 | Midazolam | Midazolam | Henry Schein, Inc. | ANDA | Current |
| 0404-9912 | Midazolam | Midazolam | Henry Schein, Inc. | ANDA | Current |
| 52584-081 | Midazolam | Midazolam | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-081 | Midazolam | Midazolam | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-081 | Midazolam | Midazolam | General Injectables and Vaccines, Inc. | ANDA | Current |
| 63323-411 | Midazolam | MIDAZOLAM HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-411 | Midazolam | MIDAZOLAM HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-411 | Midazolam | MIDAZOLAM HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-412 | Midazolam | MIDAZOLAM HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-412 | Midazolam | MIDAZOLAM HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-412 | Midazolam | MIDAZOLAM HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 65293-411 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
| 65293-411 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
| 65293-412 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
| 65293-412 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
| 65293-413 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
| 65293-413 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
| 65293-414 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
| 65293-414 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
| 65293-415 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
| 65293-415 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
| 65293-416 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
| 65293-416 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
| 65293-417 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
| 65293-417 | Midazolam | MIDAZOLAM HYDROCHLORIDE | The Medicines Company | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8541 | ORIG | 2004-06-09 |
| 30776 | ORIG | 2000-06-20 |