Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208587
Company: EMMAUS MEDCL
Company: EMMAUS MEDCL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENDARI | L-GLUTAMINE | 5GM/PACKET | FOR SOLUTION;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 |
---|---|---|---|---|---|---|---|
07/07/2017 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208587s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208587Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208587Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/29/2020 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208587s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208587Orig1s003ltr.pdf | |
04/22/2020 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208587s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208587Orig1s002ltr.pdf | |
11/01/2019 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208587s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208587Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/29/2020 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208587s003lbl.pdf | |
04/22/2020 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208587s002lbl.pdf | |
11/01/2019 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208587s001lbl.pdf | |
07/07/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208587s000lbl.pdf |