Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210291
Company: SHILPA MEDICARE LTD
Company: SHILPA MEDICARE LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | None (Tentative Approval) | 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 |
---|---|---|---|---|---|---|---|
11/09/2018 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210291Orig1s000TAltr.pdf |