Application 209566
- Type
- NDA
- Sponsor
- MERIDIAN MEDCL TECHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SEIZALAM | MIDAZOLAM HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR | EQ 50MG BASE/10ML (EQ 5MG BASE/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 11704-650 | Seizalam | midazolam hydrochloride | Meridian Medical Technologies, Inc. | NDA | Current |
| 11704-650 | Seizalam | midazolam hydrochloride | Meridian Medical Technologies, Inc. | NDA | Current |
| 11704-650 | Seizalam | midazolam hydrochloride | Meridian Medical Technologies LLC | NDA | Current |
| 11704-650 | Seizalam | midazolam hydrochloride | Meridian Medical Technologies, Inc. | NDA | Current |
| 11704-650 | Seizalam | midazolam hydrochloride | Meridian Medical Technologies, Inc. | NDA | Current |
| 11704-650 | Seizalam | midazolam hydrochloride | Meridian Medical Technologies, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73209 | SUPPL | 2023-01-17 |
| 73162 | SUPPL | 2023-01-17 |
| 66149 | SUPPL | 2021-02-09 |
| 66139 | SUPPL | 2021-02-09 |
| 60236 | ORIG | 2019-10-04 |
| 56587 | ORIG | 2018-11-29 |
| 55506 | ORIG | 2018-09-18 |