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 | REMEDYREPACK INC. | a08dadff-f209-48dc-b597-6f085be13640 | 2026-09-10 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | ScieGen Pharmaceuticals, Inc. | 23899405-007b-48d9-82a9-a530b8e90784 | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 583c5021-2948-7db4-e063-6294a90ae7dc | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 023cef65-c9c2-4d70-af66-198fb1b57714 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 71335-1482 |
| Fluoxetine HCL | FLUOXETINE HCL | Direct_rx | 48705e4f-c3ee-af78-e063-6394a90ad052 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Coupler LLC | 5386a140-7c5b-5959-e063-6294a90a2ad0 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | a9de93d4-2edc-2838-e053-2995a90a8ed6 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | d26f7450-7650-43df-a63b-1fe2472882a9 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Coupler LLC | 5020d0d6-969e-b4cd-e063-6294a90af9d2 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ef0fa849-a3a0-45d2-9258-da2d46bee089 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ec608267-9c00-4d5c-a9ed-d89503f93d28 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | e83e2220-d32a-472c-bd9f-b87d0cf8858f | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | d121146e-7439-4169-a421-dab7b882b8aa | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 70518-3554 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 8b8fe00e-7a2f-486b-9b72-465a494d8939 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 70518-3483 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | RADHA PHARMACEUTICALS, INC. | 1a07ebe9-3661-4a48-b8af-9b228875166a | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 77771-115 77771-113 77771-114 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 77d5c10a-0cfc-4b89-942c-0fb5c67ae409 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | 2c56a437-f6bf-4ac8-b1d9-fc8a605a97e7 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | 3e6b9d55-f9bb-4bf2-bc6c-975cc0d94d23 | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Northwind Health Company, LLC | aae4e339-5244-f6f9-e053-2995a90a42ce | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Northwind Health Company, LLC | ab1eec9d-f755-81a2-e053-2a95a90acb3c | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
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 |
|---|---|---|---|---|---|
| 69367-236 | Fluoxetine | Fluoxetine Hydrochloride | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-236 | Fluoxetine | Fluoxetine Hydrochloride | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-237 | Fluoxetine | Fluoxetine Hydrochloride | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-237 | Fluoxetine | Fluoxetine Hydrochloride | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-237 | Fluoxetine | Fluoxetine Hydrochloride | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-237 | Fluoxetine | Fluoxetine Hydrochloride | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 70518-0032 | FLUOXETINE | FLUOXETINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0262 | FLUOXETINE | FLUOXETINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0997 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0997 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0997 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1321 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1321 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2754 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2754 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2754 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2754 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2754 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3322 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3483 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3483 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3554 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-077 | Fluoxetine | Fluoxetine Hydrochloride | Denton Pharma, Inc. | ANDA | Current |
| 70934-077 | Fluoxetine | Fluoxetine Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-077 | Fluoxetine | Fluoxetine Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-611 | Fluoxetine | Fluoxetine Hydrochloride | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71205-125 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-125 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-974 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-974 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-974 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-975 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-975 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-975 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-979 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-979 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-979 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-0827 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0923 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1033 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1482 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1482 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1482 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1548 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1548 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1588 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-2020 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71610-683 | Fluoxetine | Fluoxetine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 77771-113 | Fluoxetine | Fluoxetine Hydrochloride | RADHA PHARMACEUTICALS, INC. | ANDA | Current |
| 77771-114 | Fluoxetine | Fluoxetine Hydrochloride | RADHA PHARMACEUTICALS, INC. | ANDA | Current |
| 77771-115 | Fluoxetine | Fluoxetine Hydrochloride | RADHA PHARMACEUTICALS, INC. | ANDA | Current |