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FDA NDA · NDA208036

VARIBAR THIN LIQUID

barium sulfate

Sponsor: BRACCO

APPLICATION
NDA208036
TYPE
NDA
ORIGINAL APPROVAL
2016-01-11
LATEST ACTION
2019-04-30
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued, Prescription

Products

E-Z-CAT DRY · ReferenceDiscontinued
BARIUM SULFATE 40% · FOR SUSPENSION · ORAL
E-Z-HD · ReferencePrescription
BARIUM SULFATE 98% · FOR SUSPENSION · ORAL
VARIBAR THIN LIQUID · ReferencePrescription
BARIUM SULFATE 81% · FOR SUSPENSION · ORAL
E-Z-PAQUE · ReferencePrescription
BARIUM SULFATE 96% · FOR SUSPENSION · ORAL

Approval history

2019-04-30Efficacy · Supplement 10 · standardLabelAP
2017-04-07Efficacy · Supplement 5 · standardLabelAP
2017-02-08Labeling · Supplement 6 · standardLabelAP
2017-01-03Efficacy · Supplement 2 · standardLabelAP
2016-01-11Type 7 - Drug Already Marketed without Approved NDA · Original · standardLabelAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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