Application 020974
- Type
- NDA
- Sponsor
- LILLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROZAC | FLUOXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | PROZAC | FLUOXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020974-001 | PROZAC | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | |
| N020974-002 | PROZAC | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1999-03-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020974-001 | PROZAC | EQ 10MG BASE | TABLET / ORAL | RLD | 1999-03-09 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020974-002 | PROZAC | EQ 20MG BASE | TABLET / ORAL | RLD | 1999-03-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020974-001 | PROZAC | EQ 10MG BASE | TABLET / ORAL | RLD | 1999-03-09 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020974-002 | PROZAC | EQ 20MG BASE | TABLET / ORAL | RLD | 1999-03-09 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020974-001 | PROZAC | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1999-03-09 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020974-002 | PROZAC | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1999-03-09 | 74a2ff9319b5… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | a08dadff-f209-48dc-b597-6f085be13640 | 2026-09-10 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Major Pharmaceuticals | 76b264ce-2a13-4511-8e21-4ffad0a327f9 | 2026-08-31 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | ScieGen Pharmaceuticals, Inc. | 23899405-007b-48d9-82a9-a530b8e90784 | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 583c5021-2948-7db4-e063-6294a90ae7dc | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | d4043133-38de-4faa-bb76-8fafa5913844 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | a04a5bed-d051-4bb4-ae20-b09b10d5c181 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | American Health Packaging | 7bee936b-0130-4a6b-a974-956aef5486d9 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 77b6ae48-8e3a-42e6-9b5a-aeed750861e8 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | fb0608d9-1ae3-43be-8a20-e9f34e955862 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | d5a267cb-08bd-4530-a7a8-2bceddd828e5 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 72e391aa-1a46-4589-8550-f83ac9241cf1 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 32afb28a-dc4c-4a7e-9701-1825f805e7df | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 20516384-6517-48be-bd6e-718250878a76 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Dr.Reddy's Laboratories Limited | 887fc670-db67-4cfe-967b-46b38375dae5 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 023cef65-c9c2-4d70-af66-198fb1b57714 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Coupler LLC | 5386a140-7c5b-5959-e063-6294a90a2ad0 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 992060ee-fb4e-4c6d-9ffe-30902bc63af2 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Par Health USA, LLC | 53ac797d-8792-4a8c-9708-d1de3d377e8f | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | a9de93d4-2edc-2838-e053-2995a90a8ed6 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7d7a196b-91de-4753-8bb6-c6d5c668952d | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.