Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 201277
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GADAVIST | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| GADAVIST | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| GADAVIST | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| GADAVIST | GADOBUTROL | 18.1416GM/30ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| GADAVIST | GADOBUTROL | 39.3068GM/65ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| GADAVIST | GADOBUTROL | 1.20944GM/2ML (604.72MG/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 |
|---|---|---|---|---|---|---|---|
| 03/14/2011 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201277s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201277s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201277Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201277Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/02/2018 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201277s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022090Orig1s016,201277Orig1s016ltr.pdf | |
| 07/26/2018 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022090Orig1s015,201277Orig1s015Ltr.pdf | |
| 04/26/2018 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201277s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201277Orig1s013Ltr.pdf | |
| 11/25/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/2016 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201277s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201277Orig1s011ltr.pdf | |
| 07/31/2015 | SUPPL-10 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201277s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201277Orig1s010ltr.pdf | |
| 06/01/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/2014 | SUPPL-8 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201277s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201277Orig1s008ltr.pdf | |
| 06/11/2014 | SUPPL-7 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201277Orig1s007ltr.pdf |
| 12/18/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/2013 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201277s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201277Orig1s003ltr_replace.pdf | |
| 07/31/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/2012 | SUPPL-1 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201277s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/02/2018 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201277s016lbl.pdf | |
| 07/26/2018 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf | |
| 07/26/2018 | SUPPL-15 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf | |
| 04/26/2018 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201277s013lbl.pdf | |
| 04/27/2016 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201277s011lbl.pdf | |
| 07/31/2015 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201277s010lbl.pdf | |
| 12/29/2014 | SUPPL-8 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201277s008lbl.pdf | |
| 10/21/2013 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201277s003lbl.pdf | |
| 03/14/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201277s000lbl.pdf |
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