← FDA DRUG APPROVALS

FDA NDA · NDA208143

VARIBAR NECTAR

barium sulfate

Sponsor: BRACCO

APPLICATION
NDA208143
TYPE
NDA
ORIGINAL APPROVAL
2016-01-15
LATEST ACTION
2022-03-10
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

VARIBAR HONEY · ReferencePrescription
BARIUM SULFATE 40% · SUSPENSION · ORAL
TAGITOL V · ReferencePrescription
BARIUM SULFATE 40% · SUSPENSION · ORAL
LIQUID E-Z-PAQUE · ReferencePrescription
BARIUM SULFATE 60% · SUSPENSION · ORAL
READI-CAT 2 · ReferencePrescription
BARIUM SULFATE 2% · SUSPENSION · ORAL
ENTERO VU 24% · ReferencePrescription
BARIUM SULFATE 24% · SUSPENSION · ORAL
VARIBAR THIN HONEY · ReferencePrescription
BARIUM SULFATE 40% · SUSPENSION · ORAL
VARIBAR NECTAR · ReferencePrescription
BARIUM SULFATE 40% · SUSPENSION · ORAL
READI-CAT 2 SMOOTHIE · ReferencePrescription
BARIUM SULFATE 2% · SUSPENSION · ORAL

Approval history

2022-03-10Manufacturing (CMC) · Supplement 13 — Letter ↗AP
2020-05-29Efficacy · Supplement 11 · standard — Label ↗AP
2018-03-26Efficacy · Supplement 7 · standard — Label ↗AP
2018-01-23Efficacy · Supplement 6 · standard — Label ↗AP
2017-08-04Efficacy · Supplement 5 · standard — Label ↗AP
2017-07-07Efficacy · Supplement 4 · standard — Label ↗AP
2017-03-01Efficacy · Supplement 2 · standard — Label ↗AP
2017-02-08Labeling · Supplement 3 · standard — Label ↗AP
2016-01-15Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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