Application 211444
- Type
- ANDA
- Sponsor
- PIRAMAL HLTHCARE UK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 002 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211444-001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | ||
| A211444-002 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 |
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 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211444-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2022-09-13 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211444-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2022-09-13 | a72a2bbeb626… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-01-26 05:58 UTC | 2023-01 | A211444-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A211444-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211444-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211444-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A211444-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A211444-002 | AB | 1 | f41ea6bd6efb… |
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 | PD-Rx Pharmaceuticals, Inc. | d26f7450-7650-43df-a63b-1fe2472882a9 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Coupler LLC | 5020d0d6-969e-b4cd-e063-6294a90af9d2 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ef0fa849-a3a0-45d2-9258-da2d46bee089 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ec608267-9c00-4d5c-a9ed-d89503f93d28 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | e83e2220-d32a-472c-bd9f-b87d0cf8858f | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | d121146e-7439-4169-a421-dab7b882b8aa | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 8b8fe00e-7a2f-486b-9b72-465a494d8939 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | RADHA PHARMACEUTICALS, INC. | 1a07ebe9-3661-4a48-b8af-9b228875166a | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 3ccada47-7eb9-285d-5059-06afb4466114 | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | bb06af33-8ff7-0b02-0029-d628f62e1382 | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 77d5c10a-0cfc-4b89-942c-0fb5c67ae409 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | 2c56a437-f6bf-4ac8-b1d9-fc8a605a97e7 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | 3e6b9d55-f9bb-4bf2-bc6c-975cc0d94d23 | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Aurobindo Pharma Limited | 45454555-7402-41cb-a452-e6a76e04f387 | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Prozac | FLUOXETINE HYDROCHLORIDE | Dista Products Company | c88f33ed-6dfb-4c5e-bc01-d8e36dd97299 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine Hydrochloride | FLUOXETINE HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 1ffe57c3-6f70-4075-aacb-d87a3990fdea | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | Fluoxetine Hydrochloride FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Northwind Health Company, LLC | da6b9b19-2ea1-9a39-e053-2995a90ad730 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Northwind Health Company, LLC | dfae4357-b6f9-9a30-e053-2995a90a2667 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Northwind Health Company, LLC | aae4e339-5244-f6f9-e053-2995a90a42ce | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Northwind Health Company, LLC | ab1eec9d-f755-81a2-e053-2a95a90acb3c | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.