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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 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 | 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… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078619-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078619-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078619-001 | 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 | 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 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | 3fba8d68-0663-4053-93ee-7531246fd47d | 2023-11-17 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 50090-6064 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | 224c8c17-0183-4cd7-ab9e-0062f3c624f0 | 2023-10-16 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 50090-6081 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 9f069b9b-16e4-4f0e-b420-4aa02ffbb632 | 2023-09-20 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 0615-8183 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Proficient Rx LP | 70e115cc-6e9b-4b96-a1a9-779ed51ad0a7 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Proficient Rx LP | ef699ed0-fd9e-4580-93bb-6fd50499dbd1 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
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 |
|---|---|---|---|---|---|
| 0615-8183 | Fluoxetine | Fluoxetine Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10544-065 | Fluoxetine | Fluoxetine Hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-180 | Fluoxetine | Fluoxetine Hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-583 | Fluoxetine | Fluoxetine Hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 16714-720 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-720 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-720 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-720 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-720 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-721 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-721 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-721 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-721 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-721 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-722 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-722 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-722 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-722 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-722 | Fluoxetine | Fluoxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 21695-052 | Fluoxetine | Fluoxetine Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 21695-053 | Fluoxetine | Fluoxetine Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 33261-045 | Fluoxetine | Fluoxetine Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 35356-728 | Fluoxetine | Fluoxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-728 | Fluoxetine | Fluoxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-728 | Fluoxetine | Fluoxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-728 | Fluoxetine | Fluoxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 43063-570 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-570 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-570 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-570 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-570 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-570 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-570 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-570 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-570 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-712 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-712 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-712 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-712 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-712 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-712 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-712 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-712 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-993 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-993 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-993 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-993 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-993 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-993 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-993 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-993 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-993 | Fluoxetine | Fluoxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 45865-368 | Fluoxetine | Fluoxetine Hydrochloride | Medsource Pharmaceuticals | ANDA | Current |
| 50090-0745 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0745 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0745 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0745 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0749 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0749 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2589 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2589 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2589 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2589 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2589 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2589 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2793 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-6064 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-6065 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-6066 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-6081 | Fluoxetine | Fluoxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50268-333 | Fluoxetine | Fluoxetine Hydrochloride | AvPAK | ANDA | Current |
| 50268-334 | Fluoxetine | Fluoxetine Hydrochloride | AvPAK | ANDA | Current |
| 50268-335 | Fluoxetine | Fluoxetine Hydrochloride | AvPAK | ANDA | Current |
| 50268-335 | Fluoxetine | Fluoxetine Hydrochloride | AvPAK | ANDA | Current |
| 50436-0924 | Fluoxetine | Fluoxetine Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-1930 | Fluoxetine | Fluoxetine Hydrochloride | Unit Dose Services | ANDA | Current |
| 51138-093 | Fluoxetine | Fluoxetine Hydrochloride | Med-Health Pharma, LLC | ANDA | Current |
| 51138-094 | Fluoxetine | Fluoxetine Hydrochloride | Med-Health Pharma, LLC | ANDA | Current |
| 51138-095 | Fluoxetine | Fluoxetine Hydrochloride | Med-Health Pharma, LLC | ANDA | Current |
| 51655-100 | fluoxetine hydrochloride | fluoxetine hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23913 | ORIG | 2008-02-28 |