Application 076022
- Type
- ANDA
- Sponsor
- CARLSBAD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE | No | No |
| 002 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 20MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076022-001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | ||
| A076022-002 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076022-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2002-01-30 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076022-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2002-01-30 | 782e0a99824c… |
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 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 | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | a04a5bed-d051-4bb4-ae20-b09b10d5c181 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | fluoxetine hydrochloride 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 | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | fb0608d9-1ae3-43be-8a20-e9f34e955862 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | fluoxetine hydrochloride 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 | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 4afdf87f-462b-4a38-9c0d-e74995c492ea | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | fluoxetine hydrochloride 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 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 | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 023cef65-c9c2-4d70-af66-198fb1b57714 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | a5fa64a6-3de3-4e2e-8b92-6d507fb8eee9 | 2026-06-05 | 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 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. | b7b102f0-17a2-49f7-b898-cb2e0fc71b4d | 2026-05-05 | 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 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | d26f7450-7650-43df-a63b-1fe2472882a9 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Coupler LLC | 5020d0d6-969e-b4cd-e063-6294a90af9d2 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23794 | ORIG | 2005-08-01 |