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US FDA source recordAL · Approval Letter

TAPENTADOL HYDROCHLORIDE — FDA Approval Letter (ANDA 219119)

Issued to NOVITIUM PHARMA. Application is approved as submitted.

Issued

February 11, 2026

Application

ANDA 505j • 219119

Product

TAPENTADOL HYDROCHLORIDE

Company

NOVITIUM PHARMA

Stage

Final Decision

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What did FDA decide for TAPENTADOL HYDROCHLORIDE?

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Source facts

FDA issued an approval letter for TAPENTADOL HYDROCHLORIDE on 2026-02-11. The source metadata identifies ANDA 219119 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 219119.
  • 3Submission: original application.
  • 4Sponsor: NOVITIUM PHARMA.

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FDAPDFUpdated Jul 30, 2026

FDA source document

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Common questions about the TAPENTADOL HYDROCHLORIDE approval letter

Is TAPENTADOL HYDROCHLORIDE FDA approved?

This letter documents an FDA approval action: FDA approved ANDA 219119 for TAPENTADOL HYDROCHLORIDE, sponsored by NOVITIUM PHARMA, on February 11, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is ANDA 219119?

ANDA 219119 is the application under which FDA issued this approval letter for TAPENTADOL HYDROCHLORIDE to NOVITIUM PHARMA. The letter is dated February 11, 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.