Application 020520
- Type
- NDA
- Sponsor
- SANOFI US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZANTAC 75 | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 75MG BASE | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0597-0122 | Zantac 75 | ranitidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0122 | Zantac 75 | ranitidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 41167-0300 | Zantac 75 | Ranitidine Hydrochloride | Chattem, Inc. | NDA | Current |
| 41167-0300 | Zantac 75 | Ranitidine Hydrochloride | Chattem, Inc. | NDA | Current |
| 50269-222 | Zantac 75 | RANITIDINE | JC World Bell Wholesale Co., Inc. | NDA | Current |
| 50269-222 | Zantac 75 | RANITIDINE | JC World Bell Wholesale Co., Inc. | NDA | Current |
| 67751-152 | Zantac 75 | RANITIDINE | Navajo Manufacturing Company Inc. | NDA | Current |
| 67751-152 | Zantac 75 | RANITIDINE | Navajo Manufacturing Company Inc. | NDA | Current |
| 68151-2584 | Zantac 75 | ranitidine | Carilion Materials Management | NDA | Current |
| 76413-317 | Zantac | ranitidine | Central Texas Community Health Centers | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 60052 | SUPPL | 2019-09-19 |
| 60046 | SUPPL | 2019-09-19 |
| 58239 | SUPPL | 2019-04-08 |
| 58238 | SUPPL | 2019-04-08 |
| 45114 | SUPPL | 2016-08-23 |
| 25102 | SUPPL | 2016-07-28 |
| 34759 | SUPPL | 2016-02-23 |
| 25101 | SUPPL | 2016-02-17 |
| 12676 | SUPPL | 2015-11-25 |
| 25100 | SUPPL | 2015-11-23 |
| 34758 | SUPPL | 2015-02-17 |
| 25099 | SUPPL | 2015-02-03 |
| 20698 | SUPPL | 2008-02-19 |
| 2657 | SUPPL | 2005-03-03 |
| 20697 | SUPPL | 1998-06-08 |