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US FDA source recordAL · Approval Letter

DILTIAZEM HYDROCHLORIDE — FDA Approval Letter (ANDA 218744)

Issued to MACLEODS PHARMS LTD. Application is approved as submitted.

Issued

March 3, 2026

Application

ANDA 505j • 218744

Product

DILTIAZEM HYDROCHLORIDE

Company

MACLEODS PHARMS LTD

Stage

Final Decision

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What did FDA decide for DILTIAZEM HYDROCHLORIDE?

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Source facts

FDA issued an approval letter for DILTIAZEM HYDROCHLORIDE on 2026-03-03. The source metadata identifies ANDA 218744 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 218744.
  • 3Submission: original application.
  • 4Sponsor: MACLEODS PHARMS LTD.

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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 DILTIAZEM HYDROCHLORIDE approval letter

Is DILTIAZEM HYDROCHLORIDE FDA approved?

This letter documents an FDA approval action: FDA approved ANDA 218744 for DILTIAZEM HYDROCHLORIDE, sponsored by MACLEODS PHARMS LTD, on March 3, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is ANDA 218744?

ANDA 218744 is the application under which FDA issued this approval letter for DILTIAZEM HYDROCHLORIDE to MACLEODS PHARMS LTD. The letter is dated March 3, 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.