Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bracco Diagnostics Inc
849234661
Manufacturing Establishments4
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Eurofins Lancaster Laboratories, Inc
Bracco Diagnostics Inc
Bracco Diagnostics Inc
069777290
Jubilant HollisterStier LLC
Bracco Diagnostics Inc
Bracco Diagnostics Inc
069263643
Sigma-Aldrich Production GmbH
Bracco Diagnostics Inc
Bracco Diagnostics Inc
480945463
Biomedical Research Foundation of Northwest Louisiana
Bracco Diagnostics Inc
Bracco Diagnostics Inc
077799604
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Choletec
Product Details
NDC Product Code
0270-0083Application Number
NDA018963Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
October 4, 2018STANNOUS FLUORIDEInactive
Code: 3FTR44B32QClass: IACTQuantity: 0.54 mg in 1 1
MebrofeninActive
Code: 7PV0B6ED98Class: ACTIBQuantity: 45 mg in 1 1
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 5.2 mg in 1 1
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.58 mg in 1 1