Source facts
FDA issued an approval letter for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE on 2026-06-08. The source metadata identifies ANDA 220483 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE — FDA Approval Letter (ANDA 220483)
Issued to SAGENT. Application is approved as submitted.
Issued
June 8, 2026Application
ANDA 505j • 220483
Product
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Company
SAGENT
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE?
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 220483.
- 3Submission: original application.
- 4Sponsor: SAGENT.
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Common questions about the NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE approval letter
Is NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 220483 for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE, sponsored by SAGENT, on June 8, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 220483?
ANDA 220483 is the application under which FDA issued this approval letter for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE to SAGENT. The letter is dated June 8, 2026.
What happens after an FDA approval letter?
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.