Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073393
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOLMETIN SODIUM | TOLMETIN SODIUM | EQ 400MG BASE | CAPSULE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/27/1993 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/09/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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07/31/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
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08/08/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
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02/05/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |