FLUOXETINE HYDROCHLORIDE | N018936 | ELI LILLY AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Premier Research FDA-2025-P-2077 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.
Eli Lilly's Prozac (fluoxetine hydrochloride) transitioned from prescription status to discontinued in the FDA database.
Old: RX
New: DISCN
Eli Lilly's Prozac (fluoxetine hydrochloride) therapeutic equivalence code changed from AB1 to a new designation for NDA 018936, affecting generic substitution eligibility.
Old: AB1
Eli Lilly discontinued Prozac (fluoxetine hydrochloride) formulation NDA 018936-001, changing its status from prescription to discontinued in the FDA database.
Old: RX
New: DISCN
Eli Lilly discontinued the Prozac (fluoxetine hydrochloride) formulation associated with NDA 018936, changing its status from prescription to discontinued.
Old: RX
New: DISCN
Eli Lilly's Prozac (fluoxetine hydrochloride) NDA 018936, Supplement 003 had its therapeutic equivalence code changed from AB to a different rating.
Old: AB
Eli Lilly's PROZAC (fluoxetine hydrochloride) therapeutic equivalence code changed from AB1 to a different rating, affecting generic substitutability determinations.
Old: AB1
Eli Lilly removed RLD (Reference Listed Drug) status from Prozac (fluoxetine hydrochloride) NDA 018936, changing its designation from a reference product to a non-reference product.
Old: Yes
New: No