RANITIDINE HYDROCHLORIDE | N019675 | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Emery Pharm on behalf of Najafi Pharma FDA-2020-P-0042 · 3 docket documents Emery Pharma, on behalf of Najafi Pharma, Inc., filed this citizen petition on January 2, 2020, requesting that the FDA recall and suspend sales of all ranitidine products (sold as Zantac®) based on preliminary stability studies showing the drug generates significant amounts of N-Nitrosodimethylamin | Other | 2020-01-03 | Partially Denied | Najafi Pharma |
Citizen Petition from Strides Pharma Inc. FDA-2017-P-6101 · 5 docket documents Strides Pharma Inc. submitted this citizen petition under 21 CFR 10.25(a) and 10.30 requesting that the FDA designate Reference Standard status for Ranitidine Capsules USP 150 mg and 300 mg (ANDA A075742) held by Dr. Reddy's Laboratories, because the current Reference Standard from Sandoz Inc. (A074 | 505(q) | 2017-10-11 | Denied | Strides Pharma Inc. |
Citizen Petition from VKT Pharma Private Limited FDA-2017-P-2836 · 4 docket documents VKT Pharma Private Limited submitted this citizen petition under 21 CFR 10.30(b)(2) requesting the FDA Commissioner designate an alternate reference listed drug and reference standard for Zantac 300 mg tablets (ranitidine) to replace the original GSK-manufactured product, which has been discontinued | 505(q) | 2017-05-05 | Denied | VKT Pharma Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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