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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208036
Company: BRACCO

Products on NDA 208036

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
E-Z-CAT DRY	BARIUM SULFATE	40% (9GM/POUCH)	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
E-Z-HD	BARIUM SULFATE	98% (334GM/BOT)	FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes
E-Z-PAQUE	BARIUM SULFATE	96% (169GM/BOT)	FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes
VARIBAR THIN LIQUID	BARIUM SULFATE	81% (120GM/BOT)	FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208036

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/11/2016	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/2016/208036s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208036Orig1s000Approvedt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208036Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2019	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208036s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208036Orig1s010ltr.pdf
02/08/2017	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208036s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208036Orig1s006ltr.pdf
04/07/2017	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208036s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208036Orig1s005ltr.pdf
01/03/2017	SUPPL-2	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208036s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208036Orig1s002ltr.pdf

Labels for NDA 208036

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2019	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208036s010lbl.pdf
04/07/2017	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208036s005lbl.pdf
02/08/2017	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208036s006lbl.pdf
02/08/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208036s006lbl.pdf
01/03/2017	SUPPL-2	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208036s002lbl.pdf
01/11/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208036s000lbl.pdf

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