FLUOXETINE HYDROCHLORIDE | N021235 | ELI LILLY AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aurobindo Pharma USA, Inc. FDA-2018-P-1853 Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) and 21 CFR 10.25(a), 10.30, and 314.93 requesting that the FDA designate Dr Reddys Laboratories Ltd.'s Fluoxetine Delayed-Release Capsules USP, 90 mg (ANDA 078572) as an alternative reference standard for conducting bioequiv | 505(q) | 2018-05-11 | Denied | Aurobindo Pharma USA |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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