Application 078619
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
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 |
|---|---|---|---|---|---|---|---|
| A078619-001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | |
| A078619-002 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | |
| A078619-003 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | RS | 2008-01-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078619-001 | AB1 |
| A078619-002 | AB1 |
| A078619-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | RS | 2008-01-31 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | RS | 2008-01-31 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | RS | 2008-01-31 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078619-001 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A078619-002 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A078619-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A078619-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078619-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078619-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078619-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078619-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078619-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078619-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078619-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078619-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078619-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078619-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078619-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078619-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078619-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078619-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078619-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078619-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078619-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078619-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078619-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078619-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078619-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078619-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078619-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078619-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078619-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078619-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078619-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078619-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078619-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078619-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078619-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078619-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078619-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078619-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078619-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078619-001 | AB1 | 1 | 79d66fd596c7… |
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 | Aurobindo Pharma Limited | 45454555-7402-41cb-a452-e6a76e04f387 | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 65862-193 65862-192 65862-194 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Northwind Health Company, LLC | da6b9b19-2ea1-9a39-e053-2995a90ad730 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Northwind Health Company, LLC | dfae4357-b6f9-9a30-e053-2995a90a2667 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 51655-981 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Northwind Health Company, LLC | cb66a702-7670-4a73-98fb-0e63151a1ffb | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | QPharma Inc | fc754dff-cecb-fc6b-e053-6394a90ab371 | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Cardinal Health 107, LLC | 06394c4b-99f4-4257-bf29-53c170c5a061 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | CouplerLLC | 3e111be4-28f0-c290-e063-6294a90a447f | 2025-09-05 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | QUALLENT PHARMACEUTICALS HEALTH LLC | 4abbd9d9-e9b1-463d-8f39-f3f50d80f58a | 2025-08-20 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | NorthStar Rx LLC | 3e1e767b-66a5-4f38-8142-84d40d447f92 | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | Aurobindo Pharma Limited | d0f00a25-1aec-42fd-a301-d3710ae3e1f3 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| FLUOXETINE | FLUOXETINE HYDROCHLORIDE | DIRECT RX | 9b8d8da5-8c06-0942-e053-2995a90aa2c9 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | 9a151528-2fe0-4059-b7b7-fcb4e80a51e3 | 2024-10-15 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | 42c4c341-8282-4961-8581-8a0430162559 | 2024-10-09 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | 2f302db0-1c88-44cf-8258-3c1c60afb5a4 | 2024-09-18 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | 1226a67f-ec09-42f6-9d1b-9ddd862ea0a0 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 50345702-9869-5335-e054-00144ff88e88 | 2024-07-09 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | NorthStar Rx LLC | 97960730-432e-4e94-bb4e-62a3157270a8 | 2024-02-12 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | 578ca8f8-86eb-4247-a0b3-50c3837a982e | 2024-01-03 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | 08f3c11c-9ba0-4c53-bf31-264725e611ea | 2023-12-05 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | BluePoint Laboratories | f89a5800-6fdb-4938-a28e-3bf1aeb1c21a | 2023-11-30 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 68001-400 68001-399 |
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 |
|---|---|---|---|---|---|
| 51655-981 | Fluoxetine | Fluoxetine Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 53002-1016 | Fluoxetine | Fluoxetine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1016 | Fluoxetine | Fluoxetine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1305 | Fluoxetine | Fluoxetine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1305 | Fluoxetine | Fluoxetine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3671 | Fluoxetine | Fluoxetine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55154-7127 | Fluoxetine | Fluoxetine Hydrochloride | Cardinal Health | ANDA | Current |
| 55700-821 | Fluoxetine | Fluoxetine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 60687-659 | Fluoxetine | Fluoxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 60760-647 | Fluoxetine | Fluoxetine Hydrochloride | St. Mary | ANDA | Current |
| 60760-647 | Fluoxetine | Fluoxetine Hydrochloride | St. Mary | ANDA | Current |
| 61919-869 | FLUOXETINE | FLUOXETINE | DIRECT RX | ANDA | Current |
| 61919-869 | FLUOXETINE | FLUOXETINE | DIRECT RX | ANDA | Current |
| 61919-869 | FLUOXETINE | FLUOXETINE | DIRECT RX | ANDA | Current |
| 61919-885 | FLUOXETINE | FLUOXETINE | Direct_Rx | ANDA | Current |
| 61919-885 | FLUOXETINE | FLUOXETINE | Direct_Rx | ANDA | Current |
| 61919-885 | FLUOXETINE | FLUOXETINE | Direct_Rx | ANDA | Current |
| 63187-069 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-069 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-069 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-069 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-081 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-081 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-081 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-081 | Fluoxetine | Fluoxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63629-1609 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1609 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1609 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1609 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1610 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1610 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1610 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1610 | Fluoxetine | Fluoxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 64205-193 | Fluoxetine | Fluoxetine Hydrochloride | ReadyMeds | ANDA | Current |
| 64725-0192 | Fluoxetine | Fluoxetine Hydrochloride | TYA Pharmaceuticals | ANDA | Current |
| 64725-0193 | Fluoxetine | Fluoxetine Hydrochloride | TYA Pharmaceuticals | ANDA | Current |
| 65862-192 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-192 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-192 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-192 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-192 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-192 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-192 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-192 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-193 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-193 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-193 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-193 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-193 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-193 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-193 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-193 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-194 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-194 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-194 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-194 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-194 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-194 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-194 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-194 | Fluoxetine | Fluoxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 66267-488 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-488 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-576 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-576 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67046-213 | Fluoxetine | Fluoxetine Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1198 | Fluoxetine | Fluoxetine | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1198 | Fluoxetine | Fluoxetine | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1198 | Fluoxetine | Fluoxetine | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1690 | Fluoxetine | Fluoxetine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1690 | Fluoxetine | Fluoxetine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68001-399 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-399 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-399 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-399 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-399 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-399 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-400 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-400 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-400 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-400 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23913 | ORIG | 2008-02-28 |