ANDA 219832, held by Zydus Pharms. Epinephrine.
As of Nov 14, 2026, ANDA 219832 (Epinephrine), held by Zydus Pharms, was first approved by FDA on Sep 14, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 14, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| EpinephrineEQ 30MG BASE/30ML (EQ 1MG BASE/ML) ยท solution;intramuscular, intravenous, subcutaneous | Epinephrine | 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
