GADOBUTROL

Zenara's GADOBUTROL (gadobutrol) received FDA approval under NDA 219146, Supplement 005.

ZENARA's gadobutrol product (NDA 219146, supplement 003) was added to the FDA products database.

Zenara's gadobutrol formulation (NDA 219146, supplement 002) received FDA approval.

Zenara's GADOBUTROL (gadobutrol) NDA 219146, supplement 004, was added to FDA approval records.

ZENARA's Gadobutrol (gadolinium-based contrast agent) received FDA approval for NDA 219146, establishing an initial product record in the agency's database.

Zenara's gadobutrol product (NDA 219146, supplement 006) was added to FDA records.