ANDA 219215, held by Gland. Acetaminophen.
As of Nov 13, 2026, ANDA 219215 (Acetaminophen), held by Gland, was first approved by FDA on Apr 2, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 2, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetaminophen500MG/50ML (10MG/ML) · solution;intravenous | Acetaminophen | Rx |
| Acetaminophen1GM/100ML (10MG/ML) · solution;intravenous | Acetaminophen | Rx |
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
