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US FDA source recordAL · Approval Letter

BUPRENORPHINE HYDROCHLORIDE — FDA Approval Letter (ANDA 090279)

Issued to RUBICON RESEARCH. Application is approved as submitted.

Issued

July 20, 2026

Application

ANDA 505j • 090279

Product

BUPRENORPHINE HYDROCHLORIDE

Company

RUBICON RESEARCH

Stage

Final Decision

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What did FDA decide for BUPRENORPHINE HYDROCHLORIDE?

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Source facts

FDA issued an approval letter for BUPRENORPHINE HYDROCHLORIDE on 2026-07-20. The source metadata identifies ANDA 090279 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Application: ANDA 090279.
  • 3Submission: supplement.
  • 4Sponsor: RUBICON RESEARCH.

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

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FDAPDFUpdated Jul 30, 2026

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Common questions about the BUPRENORPHINE HYDROCHLORIDE approval letter

Is BUPRENORPHINE HYDROCHLORIDE FDA approved?

This letter documents an FDA approval action: FDA approved ANDA 090279 for BUPRENORPHINE HYDROCHLORIDE, sponsored by RUBICON RESEARCH, on July 20, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is ANDA 090279?

ANDA 090279 is the application under which FDA issued this approval letter for BUPRENORPHINE HYDROCHLORIDE to RUBICON RESEARCH. The letter is dated July 20, 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.