Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215868
Company: EXELA PHARMA
Company: EXELA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM | 50MG/50ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM | 100MG/100ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/20/2022 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215868s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215868Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/215868Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/13/2023 | SUPPL-1 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215868s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215868Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/13/2023 | SUPPL-1 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215868s001lbl.pdf | |
07/20/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215868s000lbl.pdf |