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HYPAQUE

NDA

DIATRIZOATE MEGLUMINE | N016403 | GE HEALTHCARE

3 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

API Supply Chain3 active DMFs1 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

BIOPHORE INDIA PHARMACEUTICALS PVT LTDDIATRIZOATE MEGLUMINE

DMF 287402014

VASUDHA PHARMA CHEM LTDDIATRIZOATE MEGLUMINE USP

DMF 327372018

HONOUR LAB LTDDIATRIZOATE MEGLUMINE

DMF 344032020

ORGANICHEM CORPInactiveDIATRIZOATE MEGLUMINE USP

DMF 46861982

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 30, 2002	SUPPL -71	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 60%

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 30%

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — 30%

0 patents0 exclusivities▾

SOLUTION;URETHRAL | Approved: Approved Prior to Jan 1, 1982