Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210305
Company: CIPLA
Company: CIPLA
| 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 |
|---|---|---|---|---|---|---|---|
| 09/24/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210305Orig1s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/08/2024 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/08/2024 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/08/2024 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/08/2024 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/08/2024 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/08/2024 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/08/2024 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |