FLUOXETINE HYDROCHLORIDE | N018936 | ELI LILLY AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Premier Research FDA-2025-P-2077 · 7 docket documents Premier Research filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA confirmation that Fluoxetine Hydrochloride Capsules in 15 mg and 30 mg strengths are suitable for submission as an Abbreviated New Drug Application, with the referen | Suitability | 2025-07-01 | Open | Premier Research |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2000-P-0414 · 4 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether Prozac (Fluoxetine) Tablets, 20 mg (NDA-20-974), manufactured by Eli Lilly and Company, was voluntarily withdrawn or withheld from sale for safety or effectiveness reasons pursuant to 21 CFR 314.161 and 3 | 505(q) | 2017-05-22 | Granted | Lachman Consultant Services, Inc. |
Citizen Petition from Public Citizen Health Research Group (HRG) FDA-1991-P-0352 · 4 docket documents Public Citizen Health Research Group filed this citizen petition on May 23, 1991, requesting that the FDA immediately revise the approved labeling for fluoxetine (Prozac, manufactured by Eli Lilly and Company) to include a boxed warning regarding its association with intense, violent suicidal preocc | Other | 2014-03-17 | Denied | Public Citizen Health Research Group (HRG) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.