Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202178
Company: WATSON LABS INC
Company: WATSON LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 1.875GM/PACKET | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 3.75GM/PACKET | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
09/01/2020 | ORIG-1 | Approval |
Label is not available on this site. |