ANDA 210243, held by Granules. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 210243 (Ranitidine Hydrochloride), held by Granules, was first approved by FDA on Aug 20, 2018, with 0 approved supplements and 0 published complete response letters.
USE(S) ◾ relieves heartburn associated with acid indigestion and sour stomach ◾ prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 2018 | Original application | Approved | None posted |
| Ranitidine HydrochlorideEQ 150MG BASE · tablet;oral | Ranitidine Hydrochloride | Discontinued |
| Ranitidine HydrochlorideEQ 150MG BASE · tablet;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
