Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212599
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | BX | No | No |
| SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | 800MG | TABLET;ORAL | Prescription | BX | 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 |
|---|---|---|---|---|---|---|---|
| 07/11/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SEVELAMER HYDROCHLORIDE
There are no Therapeutic Equivalents.