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US FDA source recordAL · Approval Letter

OXYCODONE HYDROCHLORIDE — FDA Approval Letter (NDA 200534)

Issued to GENUS LIFESCIENCES. Application is approved as submitted.

Issued

June 23, 2026

Application

NDA 505b1 • 200534

Product

OXYCODONE HYDROCHLORIDE

Company

GENUS LIFESCIENCES

Stage

Final Decision

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What did FDA decide for OXYCODONE HYDROCHLORIDE?

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Source facts

FDA issued an approval letter for OXYCODONE HYDROCHLORIDE on 2026-06-23. The source metadata identifies NDA 200534 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Application: NDA 200534.
  • 3Submission: supplement.
  • 4Sponsor: GENUS LIFESCIENCES.

Suggested next step

Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.

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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 OXYCODONE HYDROCHLORIDE approval letter

Is OXYCODONE HYDROCHLORIDE FDA approved?

This letter documents an FDA approval action: FDA approved NDA 200534 for OXYCODONE HYDROCHLORIDE, sponsored by GENUS LIFESCIENCES, on June 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is NDA 200534?

NDA 200534 is the application under which FDA issued this approval letter for OXYCODONE HYDROCHLORIDE to GENUS LIFESCIENCES. The letter is dated June 23, 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.