ROPINIROLE HYDROCHLORIDE | A091395 | CHARTWELL RX SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from CellTrion, Inc. FDA-2020-P-1016 · 10 docket documents 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Release Tablets 2 mg (ANDA 201576) as an alternative reference standard for bioequivalence t | Other | 2020-03-03 | Withdrawn | CellTrion, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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