Application 214826
- Type
- NDA
- Sponsor
- Almatica Pharma, LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOREEV XR | LORAZEPAM | CAPSULE, EXTENDED RELEASE;ORAL | 1MG | No | No |
| 002 | LOREEV XR | LORAZEPAM | CAPSULE, EXTENDED RELEASE;ORAL | 2MG | No | No |
| 003 | LOREEV XR | LORAZEPAM | CAPSULE, EXTENDED RELEASE; ORAL | 3MG | No | No |
| 004 | LOREEV XR | LORAZEPAM | CAPSULE, EXTENDED RELEASE;ORAL | 1.5MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52427-658 | LOREEV XR | lorazepam | Almatica Pharma LLC | NDA | Current |
| 52427-658 | LOREEV XR | lorazepam | Almatica Pharma LLC | NDA | Current |
| 52427-661 | LOREEV XR | lorazepam | Almatica Pharma LLC | NDA | Current |
| 52427-663 | LOREEV XR | lorazepam | Almatica Pharma LLC | NDA | Current |
| 52427-663 | LOREEV XR | lorazepam | Almatica Pharma LLC | NDA | Current |
| 52427-667 | LOREEV XR | lorazepam | Almatica Pharma LLC | NDA | Current |
| 52427-667 | LOREEV XR | lorazepam | Almatica Pharma LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73278 | ORIG | 2023-01-23 |
| 73229 | SUPPL | 2023-01-17 |
| 73228 | SUPPL | 2023-01-17 |
| 73194 | SUPPL | 2023-01-17 |
| 71475 | ORIG | 2022-06-29 |
| 68497 | ORIG | 2021-08-31 |