Is there a generic for Diatrizoate meglumine?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Diatrizoate meglumine, referencing the brand CYSTOGRAFIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Diatrizoate meglumine?

CYSTOGRAFIN (NDA 010040, BRACCO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Diatrizoate meglumine are approved?

Diatrizoate meglumine is approved in the following dosage forms: injectable, solution.

FDA Orange Book · active-ingredient family

Diatrizoate meglumine

Diatrizoate meglumine is approved as 3 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CYSTOGRAFIN · NDA 010040

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, solution

Product	Applicant	Application	TE	Approved
CYSTOGRAFINRLD×6	BRACCO	NDA 010040	—	Approved Prior to Jan 1, 1982
CARDIOGRAFIN	BRACCO	NDA 011620	—	Approved Prior to Jan 1, 1982
HYPAQUE×3	GE HEALTHCARE	NDA 016403	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
ANGIOVIST 282	BAYER HLTHCARE	ANDA 087726	—	Sep 23, 1982
UROVIST MEGLUMINE DIU/CT	BAYER HLTHCARE	ANDA 087739	—	Sep 23, 1982
UROVIST CYSTO	BAYER HLTHCARE	ANDA 087729	—	Sep 23, 1982
UROVIST CYSTO PEDIATRIC	BAYER HLTHCARE	ANDA 087731	—	Sep 23, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Diatrizoate meglumine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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