Bivalirudin

ANDA 91468, held by Mylan Labs Ltd. Bivalirudin.

As of Nov 15, 2026, ANDA 91468 (Bivalirudin), held by Mylan Labs Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.

• First approved: Not approved
• Supplements approved: 0
• Complete response letters: 0

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters