Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210285
Company: SAWAI USA
Company: SAWAI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 12/21/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210285Orig1s000TA_ltr.pdf |