Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 216986
Company: GUERBET
Company: GUERBET
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELUCIREM | GADOPICLENOL | 1.4553GM/3ML (485.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
ELUCIREM | GADOPICLENOL | 3.63825GM/7.5ML (485.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
ELUCIREM | GADOPICLENOL | 4.851GM/10ML (485.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
ELUCIREM | GADOPICLENOL | 7.2765GM/15ML (485.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
ELUCIREM | GADOPICLENOL | 14.553GM/30ML (485.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
ELUCIREM | GADOPICLENOL | 24.255GM/50ML (485.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
ELUCIREM | GADOPICLENOL | 48.51GM/100ML (485.1MG/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 |
---|---|---|---|---|---|---|---|
09/21/2022 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216986s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216986Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/216986Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/23/2024 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216986s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216986Orig1s005ltr.pdf | |
08/14/2024 | SUPPL-3 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216986Orig1s003ltr.pdf |
01/26/2024 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216986s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216986Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/23/2024 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216986s005lbl.pdf | |
01/26/2024 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216986s002lbl.pdf | |
01/26/2024 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216986s002lbl.pdf | |
09/21/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216986s000lbl.pdf |