Application 202133
- Type
- NDA
- Sponsor
- ALVOGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 60MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202133-001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | RLD | 2011-10-06 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | RLD | 2011-10-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | RLD | 2011-10-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | RLD | 2011-10-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N202133-001 | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET / ORAL | AB | RLD, RS | 2011-10-06 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202133-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202133-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202133-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202133-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202133-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202133-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202133-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202133-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202133-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202133-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202133-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202133-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N202133-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N202133-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N202133-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N202133-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N202133-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202133-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N202133-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N202133-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N202133-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N202133-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N202133-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N202133-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202133-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N202133-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N202133-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202133-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N202133-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N202133-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N202133-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N202133-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N202133-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N202133-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N202133-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N202133-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N202133-001 | AB | 1 | cb3db0bc1861… |
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 | Aphena Pharma Solutions - Tennessee, LLC | 583c5021-2948-7db4-e063-6294a90ae7dc | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | d4043133-38de-4faa-bb76-8fafa5913844 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | fluoxetine hydrochloride FLUOXETINE HYDROCHLORIDE |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | a04a5bed-d051-4bb4-ae20-b09b10d5c181 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | fluoxetine hydrochloride FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | American Health Packaging | 7bee936b-0130-4a6b-a974-956aef5486d9 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 77b6ae48-8e3a-42e6-9b5a-aeed750861e8 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | fb0608d9-1ae3-43be-8a20-e9f34e955862 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | fluoxetine hydrochloride FLUOXETINE HYDROCHLORIDE |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | d5a267cb-08bd-4530-a7a8-2bceddd828e5 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | fluoxetine hydrochloride FLUOXETINE HYDROCHLORIDE |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 72e391aa-1a46-4589-8550-f83ac9241cf1 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | fluoxetine hydrochloride FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 32afb28a-dc4c-4a7e-9701-1825f805e7df | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 20516384-6517-48be-bd6e-718250878a76 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Dr.Reddy's Laboratories Limited | 887fc670-db67-4cfe-967b-46b38375dae5 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | Fluoxetine hydrochloride FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 023cef65-c9c2-4d70-af66-198fb1b57714 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | a5fa64a6-3de3-4e2e-8b92-6d507fb8eee9 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Coupler LLC | 5386a140-7c5b-5959-e063-6294a90a2ad0 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 992060ee-fb4e-4c6d-9ffe-30902bc63af2 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Par Health USA, LLC | 53ac797d-8792-4a8c-9708-d1de3d377e8f | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | fluoxetine hydrochloride FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | a9de93d4-2edc-2838-e053-2995a90a8ed6 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | b7b102f0-17a2-49f7-b898-cb2e0fc71b4d | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7d7a196b-91de-4753-8bb6-c6d5c668952d | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | d26f7450-7650-43df-a63b-1fe2472882a9 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | FLUOXETINE HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47781-600 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | Alvogen Inc. | NDA | Current |
| 47781-600 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | Alvogen Inc. | NDA | Current |
| 47781-600 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | Alvogen Inc. | NDA | Current |
| 47781-600 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | Alvogen Inc. | NDA | Current |
| 47781-600 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | Alvogen Inc. | NDA | Current |
| 49909-005 | Fluoxetine HCl | Fluoxetine HCl | Edgemont Pharmaceuticals, LLC | NDA | Current |
| 52427-576 | Fluoxetine HCl | Fluoxetine HCl | Almatica Pharma Inc. | NDA | Current |
| 52427-576 | Fluoxetine HCl | Fluoxetine HCl | Almatica Pharma Inc. | NDA | Current |
| 52427-576 | Fluoxetine HCl | Fluoxetine HCl | Almatica Pharma Inc. | NDA | Current |
| 52427-576 | Fluoxetine HCl | Fluoxetine HCl | Almatica Pharma Inc. | NDA | Current |
| 52427-576 | Fluoxetine HCl | Fluoxetine HCl | Almatica Pharma Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75245 | SUPPL | 2023-08-22 |
| 75244 | SUPPL | 2023-08-22 |
| 75181 | SUPPL | 2023-08-21 |
| 75180 | SUPPL | 2023-08-21 |
| 75179 | SUPPL | 2023-08-21 |
| 68783 | SUPPL | 2021-09-24 |
| 68782 | SUPPL | 2021-09-24 |
| 68734 | SUPPL | 2021-09-23 |
| 46746 | SUPPL | 2017-01-10 |
| 46745 | SUPPL | 2017-01-10 |
| 46744 | SUPPL | 2017-01-10 |
| 46692 | SUPPL | 2017-01-06 |
| 46691 | SUPPL | 2017-01-06 |
| 40130 | SUPPL | 2014-07-30 |
| 32191 | SUPPL | 2014-07-23 |
| 24408 | ORIG | 2012-04-24 |
| 22873 | ORIG | 2012-04-24 |
| 40129 | ORIG | 2011-10-12 |
| 32190 | ORIG | 2011-10-12 |