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NDA

BARIUM SULFATE | N208143 | BRACCO DIAGNOSTICS INC

8 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Mar 15, 2022	SUPPL -13	View Letter (PDF)
Jun 2, 2020	SUPPL -11	View Letter (PDF)
Mar 29, 2018	SUPPL -7	View Letter (PDF)
Jan 26, 2018	SUPPL -6	View Letter (PDF)
Aug 8, 2017	SUPPL -5	View Letter (PDF)
Jul 11, 2017	SUPPL -4	View Letter (PDF)
Mar 3, 2017	SUPPL -2	View Letter (PDF)
Feb 9, 2017	SUPPL -3	View Letter (PDF)
Jan 20, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (8)

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#008 — 24%

RLD

0 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: May 29, 2020

#003 — 60%

RLD

0 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: Mar 1, 2017

#001 — 2%

RLD

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Jan 15, 2016

No patent or exclusivity listings for this strength.

#002 — 2%

RLD

0 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: Jan 15, 2016

#005 — 40%

RLD

0 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: Aug 4, 2017

#007 — 40%

RLD

0 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: Mar 26, 2018

#004 — 40%

RLD

0 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: Jul 7, 2017

#006 — 40%

RLD

0 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: Jan 23, 2018