EMPAGLIFLOZIN | A212138 | ZYDUS PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Public Citizen's Health Research Group FDA-2020-P-1611 · 17 docket documents Public Citizen's Health Research Group filed this petition under Sections 502 and 505(o)(4) of the FDCA requesting that the FDA immediately add boxed warnings to all sodium-glucose cotransporter-2 inhibitor drugs (canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin) contraindicating their | Other | 2020-06-24 | Denied | Public Citizen's Health Research Group |
Citizen Petition from Foley & Lardner LLP FDA-2017-P-2674 · 7 docket documents Foley & Lardner LLP filed this citizen petition under 21 CFR 10.30, 314.93, and Section 505(j)(2)(C) of the FD&C Act requesting that the FDA permit the filing of an ANDA for Empagliflozin and Linagliptin Capsules in 10 mg/5 mg and 25 mg/5 mg strengths, which would differ from the reference product G | Other | 2017-04-28 | Withdrawn | Foley & Lardner LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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