METFORMIN HYDROCHLORIDE | A078596 | AMNEAL PHARMACEUTICALS NY LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Harman Finochem Limited FDA-2020-P-1701 · 5 docket documents Harman Finochem Limited submitted a citizen petition pursuant to 21 CFR 10.25(a) and 10.30 requesting that the FDA designate an alternative reference standard for Metformin Hydrochloride Extended Release Tablets 750 mg because the current reference standard (ANDA 078596 by Amneal Pharmaceuticals NY | Other | 2020-07-27 | Withdrawn | Harman Finochem Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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