Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011559
Company: PAR STERILE PRODUCTS
Company: PAR STERILE PRODUCTS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BREVITAL SODIUM | METHOHEXITAL SODIUM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| BREVITAL SODIUM | METHOHEXITAL SODIUM | 2.5GM/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| BREVITAL SODIUM | METHOHEXITAL SODIUM | 5GM/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| BREVITAL SODIUM | METHOHEXITAL SODIUM | 200MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/03/2020 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/011559s057lbl.pdf | |
| 04/27/2017 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011559s051lbl.pdf | |
| 01/23/2014 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011559s045lbl.pdf | |
| 05/05/2008 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011559s041lbl.pdf | |
| 05/27/2004 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11559slr037_brevital_lbl.pdf |