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US FDA source recordCRL · Complete Response Letter

MYHIBBIN — FDA Complete Response Letter (NDA 216482)

Issued to Liqmeds Worldwide Limited. Application reviewed but not approved; deficiencies must be corrected.

Issued

January 6, 2023

Application

NDA 505b1 • 216482

Product

MYHIBBIN

Company

Liqmeds Worldwide Limited

Review center

Other

Stage

Final Decision

Response due

December 31, 2024

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What did FDA decide for MYHIBBIN?

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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

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Common questions about the MYHIBBIN complete response letter

What does this complete response letter mean for MYHIBBIN?

Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Liqmeds Worldwide Limited on January 6, 2023.

What is NDA 216482?

NDA 216482 is the application under which FDA issued this complete response letter for MYHIBBIN to Liqmeds Worldwide Limited. It was reviewed by FDA Other. The letter is dated January 6, 2023.

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.