ANDA 79238, held by Pliva Hrvatska Doo. Argatroban.
As of Nov 15, 2026, ANDA 79238 (Argatroban), held by Pliva Hrvatska Doo, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 2010 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Argatroban100MG ยท injectable; injection | Argatroban | None (tentative approval) |
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