Home Applications 018936 Application 018936
Type NDA
Sponsor ELI LILLY AND CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROZAC FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Yes No 003 PROZAC FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Yes Yes 004 PROZAC FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE No No 006 PROZAC FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Yes No 007 SARAFEM FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 008 SARAFEM FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018936-001 PROZAC FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL RLD 1987-12-29 N018936-003 PROZAC FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL RLD 1999-06-15 N018936-004 PROZAC FLUOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL 1999-06-15 N018936-006 PROZAC FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL RLD 1992-12-23 N018936-007 SARAFEM FLUOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 N018936-008 SARAFEM FLUOXETINE HYDROCHLORIDE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 7 · 252 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL RLD 1987-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL RLD 1999-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL RLD 1992-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018936-007 SARAFEM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018936-008 SARAFEM EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL AB1 RLD 1987-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL AB RLD, RS 1999-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL AB1 RLD 1992-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018936-007 SARAFEM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018936-008 SARAFEM EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL AB1 RLD 1987-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL AB RLD, RS 1999-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL AB1 RLD 1992-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018936-007 SARAFEM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018936-008 SARAFEM EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL AB1 RLD 1987-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL AB RLD, RS 1999-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL AB1 RLD 1992-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018936-007 SARAFEM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018936-008 SARAFEM EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL AB1 RLD 1987-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL AB RLD, RS 1999-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL AB1 RLD 1992-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018936-007 SARAFEM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018936-008 SARAFEM EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL AB1 RLD 1987-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL AB RLD, RS 1999-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL AB1 RLD 1992-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018936-007 SARAFEM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018936-008 SARAFEM EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL AB1 RLD 1987-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL AB RLD, RS 1999-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL AB1 RLD 1992-12-23 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0777-3104 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3104 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3104 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3104 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3104 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3105 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3105 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3105 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3105 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3105 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3107 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3107 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3107 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3107 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 0777-3107 Prozac Fluoxetine hydrochloride Dista Products Company NDA Current 70518-2101 Prozac Fluoxetine hydrochloride REMEDYREPACK INC. NDA Current