Application 204597
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
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 |
|---|---|---|---|---|---|---|---|
| A204597-001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | |
| A204597-002 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | |
| A204597-003 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204597-001 | AB1 |
| A204597-002 | AB1 |
| A204597-003 | AB |
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 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204597-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204597-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204597-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204597-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204597-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204597-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204597-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204597-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204597-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204597-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204597-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204597-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204597-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204597-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204597-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204597-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204597-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204597-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204597-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204597-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204597-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204597-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204597-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204597-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204597-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204597-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2015-03-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204597-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2015-03-16 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204597-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204597-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204597-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204597-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204597-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204597-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204597-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204597-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204597-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204597-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204597-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204597-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204597-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204597-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204597-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204597-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204597-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204597-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204597-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204597-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204597-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204597-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204597-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204597-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204597-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204597-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204597-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204597-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204597-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204597-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204597-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204597-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204597-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204597-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204597-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204597-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204597-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204597-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204597-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204597-001 | AB1 | 1 | 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 | FLUOXETINE HYDROCHLORIDE | Proficient Rx LP | 0cba1992-3990-42a1-9d9a-77b593bbb02e | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 02283de9-6087-45f7-a9ce-3b082ce860de | 2019-02-01 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Vensun Pharmaceuticals, Inc. | b4f37ef1-8f5e-4318-90f1-2d8f8afb669c | 2017-09-18 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 42543-726 42543-727 42543-725 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-903 | FLUOXETINE | FLUOXETINE | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-904 | FLUOXETINE | FLUOXETINE | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-905 | FLUOXETINE | FLUOXETINE | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 42543-725 | Fluoxetine | Fluoxetine Hydrochloride | Vensun Pharmaceuticals, Inc. | ANDA | Current |
| 42543-726 | Fluoxetine | Fluoxetine Hydrochloride | Vensun Pharmaceuticals, Inc. | ANDA | Current |
| 42543-727 | Fluoxetine | Fluoxetine Hydrochloride | Vensun Pharmaceuticals, Inc. | ANDA | Current |
| 45865-359 | Fluoxetine | Fluoxetine Hydrochloride | Medsource Pharmaceuticals | ANDA | Current |
| 50090-2568 | FLUOXETINE | FLUOXETINE | A-S Medication Solutions | ANDA | Current |
| 50090-5678 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5678 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-6193 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50228-113 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-113 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-113 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-113 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-113 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-114 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-114 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-114 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-114 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-114 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-115 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-115 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-115 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-115 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-115 | Fluoxetine | Fluoxetine Hydrochloride | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50436-0726 | Fluoxetine | Fluoxetine Hydrochloride | Unit Dose Services | ANDA | Current |
| 51655-274 | Fluoxetine | Fluoxetine Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-274 | Fluoxetine | Fluoxetine Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-314 | Fluoxetine | Fluoxetine Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-314 | Fluoxetine | Fluoxetine Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 53002-1671 | Fluoxetine | Fluoxetine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1671 | Fluoxetine | Fluoxetine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-593 | Fluoxetine | Fluoxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-609 | Fluoxetine | Fluoxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-609 | Fluoxetine | Fluoxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-654 | Fluoxetine | Fluoxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-866 | Fluoxetine | Fluoxetine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-866 | Fluoxetine | Fluoxetine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 60760-311 | Fluoxetine | Fluoxetine Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-745 | FLUOXETINE | FLUOXETINE | Direct_Rx | ANDA | Current |
| 63187-361 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-361 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 66267-587 | FLUOXETINE | FLUOXETINE | NuCarePharmaceuticals, Inc. | ANDA | Current |
| 66267-587 | FLUOXETINE | FLUOXETINE | NuCarePharmaceuticals, Inc. | ANDA | Current |
| 67046-214 | FLUOXETINE | FLUOXETINE | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1568 | Fluoxetine | Fluoxetine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1568 | Fluoxetine | Fluoxetine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1568 | Fluoxetine | Fluoxetine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68071-2275 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2275 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2375 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3110 | FLUOXETINE | FLUOXETINE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3130 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4314 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4314 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4653 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5240 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5240 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5240 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5276 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5276 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6790 | FLUOXETINE | FLUOXETINE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6790 | FLUOXETINE | FLUOXETINE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6794 | FLUOXETINE | FLUOXETINE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6794 | FLUOXETINE | FLUOXETINE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7409 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7409 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7741 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7817 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7817 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7817 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7909 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7909 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69367-235 | Fluoxetine | Fluoxetine Hydrochloride | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-235 | Fluoxetine | Fluoxetine Hydrochloride | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-235 | Fluoxetine | Fluoxetine Hydrochloride | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-235 | Fluoxetine | Fluoxetine Hydrochloride | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-236 | Fluoxetine | Fluoxetine Hydrochloride | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-236 | Fluoxetine | Fluoxetine Hydrochloride | Westminster Pharmaceuticals, LLC | ANDA | Current |