CARVEDILOL | A076649 | RISING PHARMA HOLDINGS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Reference 1 Package insert for Coreg re Suitability Petition from Emprise Pha... FDA-2020-P-2166 · 8 docket documents 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appropriate for use in developing an abbreviated new drug application or generic equivale | Suitability | 2020-11-05 | Withdrawn | New Time Pharmaceutical Co, Ltd |
Citizen Petition from Keller And Heckman LLP FDA-2007-P-0058 · 11 docket documents Keller and Heckman LLP filed this suitability petition under Section 505(j)(2)(C) requesting FDA approval to file an ANDA for carvedilol phosphate in extended-release tablet form, which would differ from the reference listed drug Coreg CR (carvedilol phosphate extended-release capsules) only in dosa | Other | 2008-07-10 | Withdrawn | Keller And Heckman LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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