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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

GADOBUTROL

ANDANot in Orange Book

GADOBUTROL | A215061 | HENGRUI PHARMA

API Supply Chain9 active DMFs1 inactive

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

BAYER AGGADOBUTROL

DMF 130611998

BIOPHORE INDIA PHARMACEUTICALS PVT LTDGADOBUTROL MONOHYDRATE

DMF 334202019

JIANGSU HENGRUI PHARMACEUTICALS CO LTDGADOBUTROL USP

DMF 348322020

ST PHARM CO LTDGADOBUTROL MONOHYDRATE

DMF 356622021

FORMOSA LABORATORIES INCGADOBUTROL MONOHYDRATE

DMF 366602021

MSN LIFE SCIENCES PRIVATE LTDGADOBUTROL MONOHYDRATE USP

DMF 369962022

VIWIT PHARMACEUTICAL CO LTDGADOBUTROL

DMF 390942023

ANHUI POLY PHARM CO LTDGADOBUTROL USP

DMF 391492023

BEIJING BEILU PHARMACEUTICAL CO LTDGADOBUTROL

DMF 405332024

SICHUAN RENAN PHARMACEUTICAL CO LTDInactiveGADOBUTROL

DMF 385792023

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 20, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 1.20944GM/2ML (604.72MG/ML)

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SOLUTION;INTRAVENOUS | Approved: Nov. 17, 2022

No patent or exclusivity listings for this strength.

#002 — 4.5354GM/7.5ML (604.72MG/ML)

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SOLUTION;INTRAVENOUS | Approved: Nov. 17, 2022

#003 — 6.0472GM/10ML (604.72MG/ML)

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SOLUTION;INTRAVENOUS | Approved: Nov. 17, 2022

#004 — 9.0708GM/15ML (604.72MG/ML)

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SOLUTION;INTRAVENOUS | Approved: Nov. 17, 2022