Is there a generic for Diatrizoate meglumine; diatrizoate sodium?

Yes. The FDA Orange Book lists 11 approved generic (ANDA) applications for Diatrizoate meglumine; diatrizoate sodium, referencing the brand MD-76R. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Diatrizoate meglumine; diatrizoate sodium?

MD-76R (NDA 019292, LIEBEL-FLARSHEIM) 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; diatrizoate sodium are approved?

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

FDA Orange Book · active-ingredient family

Diatrizoate meglumine; diatrizoate sodium

Diatrizoate meglumine; diatrizoate sodium is approved as 4 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MD-76R · NDA 019292

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, solution

Product	Applicant	Application	TE	Approved
MD-76RRLD	LIEBEL-FLARSHEIM	NDA 019292	—	Sep 29, 1989
RENOGRAFIN-76RLD×4	BRACCO	NDA 010040	—	Approved Prior to Jan 1, 1982
GASTROGRAFINRLD	BRACCO	NDA 011245	AA	Approved Prior to Jan 1, 1982
HYPAQUE-M,75%×2	GE HEALTHCARE	NDA 010220	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (11)

Product	Applicant	Application	TE	Approved
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM	ANNORA PHARMA	ANDA 215049	AA	Nov 17, 2023
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM	ANDA REPOSITORY	ANDA 214201	AA	Jun 27, 2022
RENOCAL-76	BRACCO	ANDA 089347	—	Jun 01, 1988
DIATRIZOATE-60	INTL MEDICATION	ANDA 088166	—	Jun 17, 1983
ANGIOVIST 292	BAYER HLTHCARE	ANDA 087724	—	Sep 23, 1982
ANGIOVIST 370	BAYER HLTHCARE	ANDA 087723	—	Sep 23, 1982
GASTROVIST	BAYER HLTHCARE	ANDA 087728	—	Sep 23, 1982
HYPAQUE-76	GE HEALTHCARE	ANDA 086505	—	Approved Prior to Jan 1, 1982
MD-60	MALLINCKRODT	ANDA 087074	—	Approved Prior to Jan 1, 1982
MD-76	MALLINCKRODT	ANDA 087073	—	Approved Prior to Jan 1, 1982
MD-GASTROVIEW	LIEBEL-FLARSHEIM	ANDA 087388	AA	Approved Prior to Jan 1, 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; diatrizoate sodium — frequently asked questions

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

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