DICLOFENAC SODIUM | A074394 | CHARTWELL RX SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Kratz & Barry LLP on behalf of Rubicon Research Private... FDA-2019-P-2407 · 5 docket documents Kratz & Barry LLP on behalf of Rubicon Research Private Limited filed this citizen petition pursuant to Section 505(j) requesting that the FDA designate Diclofenac Sodium delayed release tablet 75 mg held by Unique Pharmaceutical Laboratories as an additional reference standard for ANDA purposes, be | Other | 2019-05-17 | Open | Rubicon Research Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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