RANITIDINE HYDROCHLORIDE | N019675 | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from VKT Pharma Private Limited FDA-2017-P-2836 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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