Issued to HOSPIRA. Application is approved as submitted.
Issued
May 4, 2026Application
NDA 505b1 • 020201
Product
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Company
HOSPIRA
Stage
Final Decision
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA issued an approval letter for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER on 2026-05-04. The source metadata identifies NDA 020201 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
This letter documents an FDA approval action: FDA approved NDA 020201 for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, sponsored by HOSPIRA, on May 4, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
NDA 020201 is the application under which FDA issued this approval letter for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER to HOSPIRA. The letter is dated May 4, 2026.
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.