Viewing data from:

GASTROGRAFIN

NDA

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | N011245 | BRACCO DIAGNOSTICS INC

1 strength0 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

Medicare Part B Spending

CMS physician-administered drug spending for Gastrografin (2023)

Total Spending

$7K

Total Claims

804

Beneficiaries

723

ASP Price

—

HCPCS: Q9963 — High osmolar contrast material, 350-399 mg/ml iodine concentration, per ml

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 31, 2005	SUPPL -32	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#003 — 66%;10%

RLDAA

0 patents0 exclusivities▴

SOLUTION;ORAL, RECTAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.