NDA 50286, held by Pfizer. Oxytetracycline Hydrochloride.
As of Nov 13, 2026, NDA 50286 (Terramycin), held by Pfizer, was first approved by FDA on Sep 8, 1964, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 8, 1964 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| TerramycinEQ 125MG BASE · capsule;oral | Oxytetracycline Hydrochloride | Discontinued |
| TerramycinEQ 250MG BASE · capsule;oral | Oxytetracycline Hydrochloride | Discontinued |
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
