Gadoversetamide | API DMFs | US Drug Master File (DMF) Details | Pharmacompass.com

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Gadoversetamide

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ACTIVE PHARMA INGREDIENTS

1 API Suppliers, 1 USDMF

FINISHED DOSAGE FORMULATIONS

32 FDF Dossiers, 9 FDA Orange Book, 23 Europe

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 1654.5MG/5ML (330.9MG/ML), INJECTABLE;INJECTION - 3309MG/10ML (330.9MG/ML), INJECTABLE;INJECTION - 4963.5MG/15ML (330.9MG/ML), INJECTABLE;INJECTION - 6618MG/20ML (330.9MG/ML), INJECTABLE;INJECTION - 16.545GM/50ML (330.9MG/ML), INJECTABLE;INJECTION - 3309MG/10ML (330.9MG/ML), INJECTABLE;INJECTION - 4963.5MG/15ML (330.9MG/ML), INJECTABLE;INJECTION - 6618MG/20ML (330.9MG/ML), INJECTABLE;INJECTION - 9927MG/30ML (330.9MG/ML)

RELATED EXCIPIENT COMPANIES

1 Kirsch Pharma, 2 Actylis, 1 Finar, 1 Microlex e.U

EXCIPIENTS BY APPLICATIONS

4 Parenteral, 1 Fillers, Diluents & Binders

DIGITAL CONTENT

2 News #PharmaBuzz

2 News #PharmaBuzz

GLOBAL SALES INFORMATION

14 Regulatory FDF Prices

14 Regulatory FDF Prices

MARKET PLACE

2 APIs

2 APIs

REF. STANDARDS & IMPURITIES

1 Others

1 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
31/10/2025	Mallinckrodt Pharmaceuticals	Ireland	MALLINCKRODT INC	17360	OPTIMARK(R) (GADOVERSETAMIDE INJECTION) PARAMETRIC RELEASE	2004-06-23	Inactive	II	N/A

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