NDA 21698, held by Chattem Sanofi. Ranitidine Hydrochloride.
As of Nov 14, 2026, NDA 21698 (Zantac 150), held by Chattem Sanofi, was first approved by FDA on Aug 31, 2004, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Zantac 150EQ 150MG BASE · tablet;oral | Ranitidine Hydrochloride | DiscontinuedReference drug |
| Zantac 150EQ 150MG BASE · tablet;oral | Ranitidine Hydrochloride | DiscontinuedReference drug |
| Sep 18, 2019 | Supplement 31Labeling · Standard review | Approved | |
| Apr 4, 2019 | Supplement 29Labeling · Standard review | Approved | |
| Aug 26, 2016 | Supplement 24Labeling · Standard review | Approved | |
| Jul 27, 2016 | Supplement 23Labeling · Standard review | Approved | |
| Mar 21, 2016 | Supplement 22Labeling · Standard review | Approved | |
| Dec 11, 2015 | Supplement 19Labeling · Standard review | Approved | |
| Nov 20, 2015 | Supplement 20Labeling · Standard review | Approved | |
| Mar 12, 2015 | Supplement 18Labeling · Standard review | Approved | |
| Dec 7, 2012 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Mar 13, 2007 | Supplement 3Manufacturing | Approved | |
| Aug 31, 2004 | Original applicationNew dosage form · Standard review | Approved |
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
