Application 078143
- Type
- ANDA
- Sponsor
- CELLTRION
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 |
| 003 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 40MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078143-001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | ||
| A078143-002 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | ||
| A078143-003 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 |
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 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078143-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078143-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078143-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078143-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078143-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078143-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078143-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078143-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078143-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078143-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078143-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078143-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078143-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078143-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078143-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078143-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078143-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078143-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078143-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078143-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078143-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078143-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078143-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078143-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078143-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | 2008-01-16 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078143-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | 2008-01-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078143-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2008-01-16 | 301d65b070ca… |
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 | Upsher-Smith Laboratories, LLC | be2e4325-feb9-4957-99c0-0a741a2d71a0 | 2023-10-06 | Boxed warning, Warnings, Adverse reactions | Fluoxetine hydrochloride FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | c4eeae3d-ae56-4e7e-b07d-02851f12039f | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | MARKSANS PHARMA LIMITED | 8e822937-9431-446f-88c4-330a25d12439 | 2023-09-26 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 9f069b9b-16e4-4f0e-b420-4aa02ffbb632 | 2023-09-20 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Lannett Company, Inc. | c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1 | 2023-08-28 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | a5d49dee-a7de-44d8-80b5-1aeb89e76938 | 2023-08-05 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine Hydrochloride | FLUOXETINE HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | dd659085-c32d-4d35-9d4b-bafa2a93f1fb | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | Fluoxetine Hydrochloride FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 06582152-d7d3-4e87-8c13-a4416a6ec927 | 2023-04-05 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Calvin Scott & Co., Inc. | 3453755b-3ed6-47a3-b4c7-c64758e7784c | 2023-03-16 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine Hydrochloride | FLUOXETINE HYDROCHLORIDE | Alembic Pharmaceuticals Limited | 9c5112c0-c721-4086-9a75-3b7f931430bb | 2023-01-25 | Boxed warning, Warnings, Adverse reactions | Fluoxetine Hydrochloride FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Proficient Rx LP | 70e115cc-6e9b-4b96-a1a9-779ed51ad0a7 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Proficient Rx LP | ef699ed0-fd9e-4580-93bb-6fd50499dbd1 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Proficient Rx LP | 57f21f2b-0ec2-49dc-911a-806e5ae880c2 | 2022-03-01 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Proficient Rx LP | a6457d6e-5586-40e9-883d-352ee0527d80 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Proficient Rx LP | 0cba1992-3990-42a1-9d9a-77b593bbb02e | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 02283de9-6087-45f7-a9ce-3b082ce860de | 2019-02-01 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Vensun Pharmaceuticals, Inc. | b4f37ef1-8f5e-4318-90f1-2d8f8afb669c | 2017-09-18 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23895 | ORIG | 2008-01-30 |