Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210249
Company: EUGIA PHARMA
Company: EUGIA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POMALIDOMIDE | POMALIDOMIDE | 1MG | CAPSULE;ORAL | Discontinued | None | No | No |
POMALIDOMIDE | POMALIDOMIDE | 2MG | CAPSULE;ORAL | Discontinued | None | No | No |
POMALIDOMIDE | POMALIDOMIDE | 3MG | CAPSULE;ORAL | Discontinued | None | No | No |
POMALIDOMIDE | POMALIDOMIDE | 4MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
10/30/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210249Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/28/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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05/28/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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05/28/2021 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |