METFORMIN HYDROCHLORIDE | A078596 | AMNEAL PHARMACEUTICALS NY LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Macleods Pharmaceuticals Limited FDA-2020-P-1792 Macleods Pharmaceuticals Limited filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate a suitable reference standard for metformin hydrochloride extended-release tablets 750 mg to support ANDA submissions, as the current refere | 505(q) | 2020-08-21 | Withdrawn | Macleods Pharmaceuticals Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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