ANDA 78192, held by Dr Reddys Labs Ltd. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 78192 (Ranitidine Hydrochloride), held by Dr Reddys Labs Ltd, was first approved by FDA on Aug 31, 2007, with 2 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 31, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ranitidine HydrochlorideEQ 150MG BASE · tablet;oral | Ranitidine Hydrochloride | OTC |
| Nov 25, 2015 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jan 18, 2012 | Supplement 10Manufacturing | Approved | None posted |
| Aug 31, 2007 | Original application | Approved | None posted |
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
