NDA 20745, held by Chattem Sanofi. Ranitidine Hydrochloride.
As of Nov 13, 2026, NDA 20745 (Zantac 75), held by Chattem Sanofi, was first approved by FDA on Feb 26, 1998, with 1 approved supplement and 0 published complete response letters.
| Mar 8, 1999 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | None posted |
| Feb 26, 1998 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zantac 75EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, effervescent;oral | Ranitidine Hydrochloride | DiscontinuedReference drug |
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
