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US FDA source recordCRL · Complete Response Letter

Unknown — FDA Complete Response Letter (NDA 218224)

Issued to Baxter Healthcare Corporation. Application reviewed but not approved; deficiencies must be corrected.

Issued

March 29, 2024

Application

NDA 505b1 • 218224

Product

Unknown

Company

Baxter Healthcare Corporation

Review center

CDER

Stage

Final Decision

Response due

March 29, 2025

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What did FDA decide for Unknown?

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Source facts

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

Key details in this letter

  • 1Labeling, packaging, and proprietary name: 16 source-text matches.
Labeling, packaging, and proprietary name

Suggested next step

Review the exact redacted FDA letter and address each stated deficiency before resubmission.

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Built from structured FDA metadata and deterministic source-text signals. Topic matches are navigation aids, not legal or regulatory conclusions. Verify material decisions against the original FDA document.

FDAPDFUpdated Jul 30, 2026

FDA source document

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Common questions about the Unknown complete response letter

What does this complete response letter mean for Unknown?

Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Baxter Healthcare Corporation on March 29, 2024.

What is NDA 218224?

NDA 218224 is the application under which FDA issued this complete response letter for Unknown to Baxter Healthcare Corporation. It was reviewed by FDA CDER. The letter is dated March 29, 2024.

What happens after an FDA complete response letter?

FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.