CARVEDILOL | N020297 | WAYLIS THERAPEUTICS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
GlaxoSmithKline LLC et al v. Teva Pharmaceuticals USA Inc. 2 patentsANDA 76-373carvedilol | D. Del. | 2014-07-03 | Terminated 2026-02-10 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Reference 2 Package insert for Coreg CR re Suitability Petition from Emprise ... FDA-2020-P-2166 Emprise Pharma LLC, on behalf of New Time Pharmaceutical Co, Ltd, filed a citizen petition requesting that the FDA determine the suitability of the Coreg CR package insert as a reference standard for an ANDA submission. The petition seeks FDA guidance on whether the existing Coreg CR labeling can be | Suitability | 2020-11-05 | Open | Emprise Pharma LLC |
Reference 3 Pharmacokinetic Properties of a New Controlled-Release Formulatio... FDA-2020-P-2166 Emprise Pharma LLC, on behalf of New Time Pharmaceutical Co, Ltd, filed a petition regarding the pharmacokinetic properties and suitability of a new controlled-release formulation of carvedilol. The petitioner sought FDA guidance or determination on whether the proposed controlled-release formulatio | Suitability | 2020-11-05 | Open | Emprise Pharma LLC |
Reference 1 Package insert for Coreg re Suitability Petition from Emprise Pha... FDA-2020-P-2166 Emprise Pharma LLC, on behalf of New Time Pharmaceutical Co, Ltd, filed a suitability petition regarding the reference package insert for Coreg, seeking FDA confirmation that the reference product's labeling is appropriate for use in developing an abbreviated new drug application or generic equivale | Suitability | 2020-11-05 | Open | Emprise Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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