Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201277
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
07/12/2019 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201277s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201277Orig1s017ltr.pdf
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-Medication Guide, Labeling-Package Insert 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
07/12/2019 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201277s017lbl.pdf
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf
07/26/2018 SUPPL-15 Labeling-Package Insert 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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