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 | Major Pharmaceuticals | 76b264ce-2a13-4511-8e21-4ffad0a327f9 | 2026-08-31 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | American Health Packaging | 7bee936b-0130-4a6b-a974-956aef5486d9 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | American Health Packaging | 9965a672-7842-4926-9063-b76317c74862 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 32afb28a-dc4c-4a7e-9701-1825f805e7df | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 70518-1174 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 20516384-6517-48be-bd6e-718250878a76 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 70518-0417 |
| Fluoxetine | FLUOXETINE | Unit Dose Solutions, Inc. | 54d9f02c-95ea-99b1-e063-6294a90a9140 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | QPharma Inc | 50253c6e-de36-05e6-e063-6294a90ad7a8 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 992060ee-fb4e-4c6d-9ffe-30902bc63af2 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | PD-Rx Pharmaceuticals, Inc. | 5dc20c8f-0d8f-400c-b850-fe1b7e3e75e3 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7d7a196b-91de-4753-8bb6-c6d5c668952d | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | REMEDYREPACK INC. | b8666383-462d-4a21-8f49-1d572da386d1 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | REMEDYREPACK INC. | d1c768b5-64bb-4036-aa92-797b3a5f92eb | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | Northwind Health Company, LLC | 50369762-c7c3-d58e-e063-6294a90af8df | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | A-S Medication Solutions | 679e439a-d955-4b54-8236-a2ccd9a2a10a | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | A-S Medication Solutions | 3ce2f189-4386-4d0d-84f6-6d913ad1c09b | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | NCS HealthCare of KY, LLC dba Vangard Labs | faf4bc0c-bf65-4a65-8f08-3d800185d6a8 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | BluePoint Laboratories | daf33244-1348-4c34-b44c-9e35d5c48a3e | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 3ccada47-7eb9-285d-5059-06afb4466114 | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | bb06af33-8ff7-0b02-0029-d628f62e1382 | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | A-S Medication Solutions | 2c8970ad-2266-4653-b7eb-4c79ba926d89 | 2026-03-03 | 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 |
|---|---|---|---|---|---|
| 68001-400 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-400 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-401 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-401 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-401 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-401 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-401 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-401 | Fluoxetine | Fluoxetine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68071-3133 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3133 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3284 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3284 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4043 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4542 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4542 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4671 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4671 | Fluoxetine | Fluoxetine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-101 | Fluoxetine | Fluoxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-101 | Fluoxetine | Fluoxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-101 | Fluoxetine | Fluoxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-101 | Fluoxetine | Fluoxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-605 | Fluoxetine | Fluoxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-605 | Fluoxetine | Fluoxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-605 | Fluoxetine | Fluoxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-605 | Fluoxetine | Fluoxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68788-7356 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7356 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7356 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7356 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7356 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9222 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9222 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9222 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9222 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9222 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9223 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9223 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9223 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9223 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9223 | Fluoxetine | Fluoxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0369 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0369 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0369 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0369 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0369 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0369 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0369 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0369 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0369 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0417 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0417 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0417 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0417 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0417 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0417 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0417 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0417 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0417 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1174 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1174 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1174 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1174 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1174 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1174 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1174 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1359 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1359 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1359 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1359 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1359 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1359 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1359 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1359 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2134 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2134 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2134 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2134 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2134 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2134 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2134 | Fluoxetine | Fluoxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23913 | ORIG | 2008-02-28 |