ROPINIROLE HYDROCHLORIDE | N022008 | GLAXOSMITHKLINE LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from CellTrion, Inc. FDA-2020-P-1016 Celltrion, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Dr. Reddy's Laboratories Ltd's Ropinirole Hydrochloride Extended Release Tablets 2 mg (ANDA 201576) as an alternative reference standard for bioequivalence t | Other | 2020-03-03 | Withdrawn | CellTrion, Inc. |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2009-P-0170 Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether Requip XL (ropinirole hydrochloride) Extended-release Tablets, 3 mg base (NDA 22-008), manufactured by SmithKline Beecham, was voluntarily withdrawn or withheld from sale for safety | 505(q) | 2009-04-03 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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