Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090631
Company: IMPAX LABS
Company: IMPAX LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET, ORALLY DISINTEGRATING;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 |
---|---|---|---|---|---|---|---|
06/08/2010 | ORIG-1 | Approval |
Label is not available on this site. |