RANITIDINE HYDROCHLORIDE | A074655 | SANDOZ INC
| 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. |
Citizen Petition from Novitium Pharma LLC FDA-2016-P-3465 Novitium Pharma LLC filed this citizen petition under 21 CFR 10.30 requesting that the FDA designate Dr. Reddy's Laboratories Ltd's Ranitidine Capsule product (ANDA A075742) as a second reference listed drug for Ranitidine Capsule 150mg and 300mg (ANDA A074655), since the original RLD manufacturer S | 505(q) | 2016-10-21 | Withdrawn | Novitium Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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