Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018163
Company: SPECGX LLC
Company: SPECGX LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RESTORIL | TEMAZEPAM | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| RESTORIL | TEMAZEPAM | 30MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| RESTORIL | TEMAZEPAM | 7.5MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| RESTORIL | TEMAZEPAM | 22.5MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018163s071lbl.pdf | |
| 02/05/2021 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018163s067lbl.pdf | |
| 02/06/2019 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018163s065lbl.pdf | |
| 12/16/2016 | SUPPL-64 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf | |
| 12/16/2016 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf | |
| 11/08/2010 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018163s054lbl.pdf | |
| 02/25/2008 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf | |
| 02/25/2008 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf |