List of Excipients in API gadobutrol

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Excipients in NDA-approved (novel) drugs containing gadobutrol

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Bayer HealthCare Pharmaceuticals Inc	GADAVIST	gadobutrol	50419-325	HYDROCHLORIC ACID
Bayer HealthCare Pharmaceuticals Inc	GADAVIST	gadobutrol	50419-325	TROMETHAMINE
Bayer HealthCare Pharmaceuticals Inc	GADAVIST	gadobutrol	50419-325	WATER
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing gadobutrol

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Company	Ingredient	NDC	Excipient
Fresenius Kabi USA LLC	gadobutrol	65219-281	CALCOBUTROL SODIUM
Fresenius Kabi USA LLC	gadobutrol	65219-281	HYDROCHLORIC ACID
Fresenius Kabi USA LLC	gadobutrol	65219-281	TROMETHAMINE
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for gadobutrol

Excipient focus: CALCOBUTROL SODIUM

gadobutrol drug variants containing CALCOBUTROL SODIUM

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Company	Ingredient	NDC
Fresenius Kabi USA LLC	gadobutrol	65219-281
Fresenius Kabi USA LLC	gadobutrol	65219-287
Slate Run Pharmaceuticals LLC	gadobutrol	70436-122
>Company	>Ingredient	>NDC

gadobutrol drug variants not containing CALCOBUTROL SODIUM

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Company	Ingredient	NDC
Bayer HealthCare Pharmaceuticals Inc	gadobutrol	50419-325
>Company	>Ingredient	>NDC

Excipient focus: HYDROCHLORIC ACID

gadobutrol drug variants containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
Bayer HealthCare Pharmaceuticals Inc	gadobutrol	50419-325
Fresenius Kabi USA LLC	gadobutrol	65219-281
Fresenius Kabi USA LLC	gadobutrol	65219-287
>Company	>Ingredient	>NDC

gadobutrol drug variants not containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: TROMETHAMINE

gadobutrol drug variants containing TROMETHAMINE

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Company	Ingredient	NDC
Bayer HealthCare Pharmaceuticals Inc	gadobutrol	50419-325
Fresenius Kabi USA LLC	gadobutrol	65219-281
Fresenius Kabi USA LLC	gadobutrol	65219-287
>Company	>Ingredient	>NDC

gadobutrol drug variants not containing TROMETHAMINE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: WATER

gadobutrol drug variants containing WATER

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Company	Ingredient	NDC
Bayer HealthCare Pharmaceuticals Inc	gadobutrol	50419-325
Fresenius Kabi USA LLC	gadobutrol	65219-281
Fresenius Kabi USA LLC	gadobutrol	65219-287
>Company	>Ingredient	>NDC

gadobutrol drug variants not containing WATER

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Company	Ingredient	NDC
Slate Run Pharmaceuticals LLC	gadobutrol	70436-122
Slate Run Pharmaceuticals LLC	gadobutrol	70436-212
Slate Run Pharmaceuticals LLC	gadobutrol	70436-216
>Company	>Ingredient	>NDC

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