Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215304
Company: HENGRUI PHARMA
Company: HENGRUI PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | No | No |
| GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | No | No |
| GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 5.6535GM/15ML (376.9MG/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | No | No |
| GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 7.538GM/20ML (376.9MG/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | No | No |
| GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 04/11/2022 | ORIG-1 | Approval | STANDARD |
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