ANDA 75557, held by Teva. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 75557 (Ranitidine Hydrochloride), held by Teva, was first approved by FDA on Oct 31, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 2003 | Original application | Approved | None posted |
| Ranitidine HydrochlorideEQ 150MG BASE · capsule;oral | Ranitidine Hydrochloride | Discontinued |
| Ranitidine HydrochlorideEQ 300MG BASE · capsule;oral | Ranitidine 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
