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US FDA source recordAL · Approval Letter

PROPRANOLOL HYDROCHLORIDE — FDA Approval Letter (ANDA 219165)

Issued to PAI HOLDINGS. Application is approved as submitted.

Issued

July 22, 2026

Application

ANDA 505j • 219165

Product

PROPRANOLOL HYDROCHLORIDE

Company

PAI HOLDINGS

Stage

Final Decision

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What did FDA decide for PROPRANOLOL HYDROCHLORIDE?

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Source facts

FDA issued an approval letter for PROPRANOLOL HYDROCHLORIDE on 2026-07-22. The source metadata identifies ANDA 219165 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 219165.
  • 3Submission: original application.
  • 4Sponsor: PAI HOLDINGS.

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FDAPDFUpdated Jul 30, 2026

FDA source document

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Common questions about the PROPRANOLOL HYDROCHLORIDE approval letter

Is PROPRANOLOL HYDROCHLORIDE FDA approved?

This letter documents an FDA approval action: FDA approved ANDA 219165 for PROPRANOLOL HYDROCHLORIDE, sponsored by PAI HOLDINGS, on July 22, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is ANDA 219165?

ANDA 219165 is the application under which FDA issued this approval letter for PROPRANOLOL HYDROCHLORIDE to PAI HOLDINGS. The letter is dated July 22, 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.