Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040590
Company: MIKART
Company: MIKART
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERGOTAMINE TARTRATE AND CAFFEINE | CAFFEINE; ERGOTAMINE TARTRATE | 100MG;1MG | TABLET;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 |
---|---|---|---|---|---|---|---|
09/16/2005 | 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 |
---|---|---|---|---|---|
06/14/2024 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
06/14/2024 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |