Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208143
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIQUID E-Z-PAQUE BARIUM SULFATE 60% (213GM/BOT) SUSPENSION;ORAL Prescription None Yes Yes
READI-CAT 2 BARIUM SULFATE 2% (9GM/BOT) SUSPENSION;ORAL Prescription None Yes Yes
READI-CAT 2 SMOOTHIES BARIUM SULFATE 2% (9GM/BOT) SUSPENSION;ORAL Prescription None Yes Yes
TAGITOL V BARIUM SULFATE 40% (8GM/BOT) SUSPENSION;ORAL Prescription None Yes Yes
VARIBAR HONEY BARIUM SULFATE 40% (100GM/250ML) SUSPENSION;ORAL Prescription None Yes Yes
VARIBAR NECTAR BARIUM SULFATE 40% (96GM/240ML) SUSPENSION;ORAL Prescription None Yes Yes
VARIBAR THIN HONEY BARIUM SULFATE 40% (100GM/250ML) SUSPENSION;ORAL 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
01/15/2016 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208143s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208143Orig1s000Approvedt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208143_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/26/2018 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208143s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208143Orig1s007ltr.pdf
01/23/2018 SUPPL-6 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208143s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208143Orig1s006ltr.pdf
08/04/2017 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Label for TAGITOL V https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208143Orig1s005ltr.pdf
07/07/2017 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Label for VARIBAR NECTAR https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208143Orig1s004ltr.pdf
02/08/2017 SUPPL-3 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208143Orig1s003ltr.pdf
03/01/2017 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208143Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/26/2018 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208143s007lbl.pdf
01/23/2018 SUPPL-6 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208143s006lbl.pdf
08/04/2017 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) Label for TAGITOL V https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s005lbl.pdf
07/07/2017 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF) Label for VARIBAR NECTAR https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s004lbl.pdf
03/01/2017 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s002lbl.pdf
02/08/2017 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s003lbl.pdf
01/15/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208143s000lbl.pdf

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