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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208143
Company: BRACCO

Products on NDA 208143

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENTERO VU 24%	BARIUM SULFATE	24% (144GM/600ML)	SUSPENSION;ORAL	Prescription	None	Yes	Yes
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 SMOOTHIE	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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208143

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	Letter and Label for READI-CAT and READI-CAT 2 SMOOTHIE	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
03/10/2022	SUPPL-13	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208143Orig1s013ltr.pdf
05/29/2020	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF)	Letter and Label for ENTERO VU 24%	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208143s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208143Orig1s011ltr.pdf
03/26/2018	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)	Letter and Label for VARIBAR HONEY	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)	Letter and Label for VARIBAR THIN HONEY	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)	Letter and Label for READI-CAT and READI-CAT 2 SMOOTHIE	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)	Letter and Label for LIQUID E-Z-PAQUE	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208143Orig1s002ltr.pdf

Labels for NDA 208143

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2020	SUPPL-11	Efficacy-New Indication	Label (PDF)	Letter and Label for ENTERO VU 24%	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208143s011lbl.pdf
03/26/2018	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)	Letter and Label for VARIBAR HONEY	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208143s007lbl.pdf
01/23/2018	SUPPL-6	Efficacy-New Patient Population	Label (PDF)	Letter and Label for VARIBAR THIN HONEY	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)	Letter and Label for LIQUID E-Z-PAQUE	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s002lbl.pdf
02/08/2017	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)	Letter and Label for READI-CAT and READI-CAT 2 SMOOTHIE	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s003lbl.pdf
01/15/2016	ORIG-1	Approval	Label (PDF)	Letter and Label for READI-CAT and READI-CAT 2 SMOOTHIE	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208143s000lbl.pdf

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