Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 219627
Company: BAYER HEALTHCARE
Company: BAYER HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMBELVIST | GADOQUATRANE | 0.5158GM/2ML (257.9MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| AMBELVIST | GADOQUATRANE | 1.93425GM/7.5ML (257.9MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| AMBELVIST | GADOQUATRANE | 2.579GM/10ML (257.9MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| AMBELVIST | GADOQUATRANE | 3.8685GM/15ML (257.9MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| AMBELVIST | GADOQUATRANE | 7.737GM/30ML (257.9MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| AMBELVIST | GADOQUATRANE | 16.7635GM/65ML (257.9MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 06/12/2026 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219627Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219627Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/219627Orig1s000TOC.html |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/12/2026 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219627Orig1s000lbl.pdf |