RANITIDINE HYDROCHLORIDE | N020095 | GLAXOSMITHKLINE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Strides Pharma Inc. FDA-2017-P-6101 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. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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