CLARITHROMYCIN | A065178 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Xiromed, LLC on behalf of LifePharma FZE FDA-2017-P-5205 · 4 docket documents Xiromed, LLC filed this petition on behalf of LifePharma FZE requesting that the FDA designate ANDA 065489 held by Aurobindo Pharma LTD as a Reference Standard for clarithromycin tablets 250 mg and 300 mg, since the original Reference Listed Drug BIAXIN (NDA 050662) held by Abbvie has been discontin | 505(q) | 2017-08-25 | Open | LifePharma FZE |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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