Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 214826
Company: ALMATICA
Company: ALMATICA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOREEV XR | LORAZEPAM | 1MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| LOREEV XR | LORAZEPAM | 2MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| LOREEV XR | LORAZEPAM | 3MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
| LOREEV XR | LORAZEPAM | 1.5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/27/2021 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214826s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214826Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214826Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214826s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214826Orig1s003ltr.pdf | |
| 01/13/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214826s003lbl.pdf | |
| 01/13/2023 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214826s003lbl.pdf | |
| 08/27/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214826s000lbl.pdf |