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US FDA source recordAL · Approval Letter

BUPROPION HYDROCHLORIDE — FDA Approval Letter (ANDA 216051)

Issued to AUROBINDO PHARMA LTD. Application is approved as submitted.

Issued

July 24, 2026

Application

ANDA 505j • 216051

Product

BUPROPION HYDROCHLORIDE

Company

AUROBINDO PHARMA LTD

Stage

Final Decision

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What did FDA decide for BUPROPION HYDROCHLORIDE?

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Source facts

FDA issued an approval letter for BUPROPION HYDROCHLORIDE on 2026-07-24. The source metadata identifies ANDA 216051 as an original application. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Application: ANDA 216051.
  • 3Submission: original application.
  • 4Sponsor: AUROBINDO PHARMA LTD.

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

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FDAPDFUpdated Jul 30, 2026

FDA source document

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Common questions about the BUPROPION HYDROCHLORIDE approval letter

Is BUPROPION HYDROCHLORIDE FDA approved?

This letter documents an FDA approval action: FDA approved ANDA 216051 for BUPROPION HYDROCHLORIDE, sponsored by AUROBINDO PHARMA LTD, on July 24, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is ANDA 216051?

ANDA 216051 is the application under which FDA issued this approval letter for BUPROPION HYDROCHLORIDE to AUROBINDO PHARMA LTD. The letter is dated July 24, 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.