Fluoxetine
- Product NDC
- 55700-593
- 11-digit product format
- 557000593
- Labeler code
- 55700
- Product ID
- 55700-593_8e1c5c71-0f26-4027-a530-37af395d6c4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA204597
- Marketing category
- ANDA
- Marketing start
- 2015-03-16
- Marketing end
- 0000-00-00
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 55700-593 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 55700-593 | 55700-593-90 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-593-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-593-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-593-90 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-593-90 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-593-90 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55700-593-90 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55700-593-90 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 55700-593-90 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 55700-593-90 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 55700-593-90 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 55700-593-90 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 55700-593-90 | 557ba5c1ecfa… | 9c80585c8c6e… |
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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-593-90 | EA - Each | 55700-593 | 69308b9c-1de2-4420-9e33-d9cc1d11d757 | 1 | 2018-05-09 |
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 | A-S Medication Solutions | cdf3b608-e14c-474b-b80e-01ac5f701866 | 2025-10-18 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | cca9edf9-2454-4bf9-98e8-c531a8f5dc42 | 2025-10-18 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Redpharm Drug | 0b3da881-475d-cdee-e063-6394a90aee99 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine HCL | FLUOXETINE HCL | Direct_Rx | 0259db51-e1ff-6e7a-e063-6394a90abace | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE | Advanced Rx Pharmacy of Tennessee, LLC | f917063a-226e-0978-e053-6294a90aeb4b | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | be4c5102-e0aa-3b89-e053-2a95a90a5d9d | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | e15646e0-a431-4b3d-8d6f-7a3d0dadfcc6 | 2024-08-23 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 3d5d03ff-0d0c-429f-b747-31ff3465d39d | 2024-08-23 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | b1409772-e719-67f5-e053-2995a90ab5b6 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | a32f1a0b-a9ee-883a-e053-2a95a90a8c12 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | a7bea6e9-cf90-a963-e053-2a95a90a1068 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Calvin Scott & Co., Inc. | 4915e22f-cecb-4261-8389-9bb417a20e82 | 2024-04-18 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Medsource Pharmaceuticals | 1302fc08-d5fa-54b4-e063-6394a90a5275 | 2024-03-06 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | a408c325-d2d5-4e88-85ce-96913eb58183 | 2023-10-24 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | c4eeae3d-ae56-4e7e-b07d-02851f12039f | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | a5d49dee-a7de-44d8-80b5-1aeb89e76938 | 2023-08-05 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 06582152-d7d3-4e87-8c13-a4416a6ec927 | 2023-04-05 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Calvin Scott & Co., Inc. | 3453755b-3ed6-47a3-b4c7-c64758e7784c | 2023-03-16 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Proficient Rx LP | 57f21f2b-0ec2-49dc-911a-806e5ae880c2 | 2022-03-01 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Proficient Rx LP | a6457d6e-5586-40e9-883d-352ee0527d80 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 204597 ANDA204597 |