Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200826
Company: IMPAX LABS INC
Company: IMPAX LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
URSODIOL | URSODIOL | 250MG | TABLET;ORAL | Discontinued | None | No | No |
URSODIOL | URSODIOL | 500MG | TABLET;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 |
---|---|---|---|---|---|---|---|
12/23/2011 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/17/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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06/23/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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05/22/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |