Application 205583
- Type
- NDA
- Sponsor
- SUN PHARMA GLOBAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DESVENLAFAXINE | DESVENLAFAXINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG BASE | Yes | No |
| 002 | DESVENLAFAXINE | DESVENLAFAXINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 100MG BASE | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N205583-001 | DESVENLAFAXINE | DESVENLAFAXINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | |
| N205583-002 | DESVENLAFAXINE | DESVENLAFAXINE FUMARATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 |
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 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205583-001 | DESVENLAFAXINE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205583-002 | DESVENLAFAXINE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2014-01-28 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| DESVENLAFAXINE | DESVENLAFAXINE | NuCare Pharmaceuticals,Inc. | 2dce1542-ead5-1b24-e063-6294a90a6df0 | 2025-02-17 | Boxed warning, Warnings, Adverse reactions | DESVENLAFAXINE |
| DESVENLAFAXINE | DESVENLAFAXINE | Bryant Ranch Prepack | 5b6e86bc-24a3-4f8c-aff7-6e1e17a7d1a4 | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | DESVENLAFAXINE |
| desvenlafaxine | DESVENLAFAXINE SUCCINATE | DIRECT RX | b3ef2bb2-c336-2d57-e053-2995a90a5fe0 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | desvenlafaxine |
| Desvenlafaxine | DESVENLAFAXINE | A-S Medication Solutions | 7107a864-fcb3-4cbf-9fcb-061bef13be2d | 2024-12-03 | Boxed warning, Warnings, Adverse reactions | Desvenlafaxine |
| Desvenlafaxine | DESVENLAFAXINE SUCCINATE | Bryant Ranch Prepack | 5e78c812-7fe6-4a4e-8465-0415df2e9851 | 2024-11-01 | Boxed warning, Warnings, Adverse reactions | Desvenlafaxine |
| Desvenlafaxine | DESVENLAFAXINE SUCCINATE | Bryant Ranch Prepack | f99c78ef-5a0a-45af-9b4b-5a78b75fe994 | 2024-10-29 | Boxed warning, Warnings, Adverse reactions | Desvenlafaxine |
| Desvenlafaxine | DESVENLAFAXINE SUCCINATE | Bryant Ranch Prepack | c7c77c4d-dd04-4780-9fa4-8fea30aff8f9 | 2024-10-29 | Boxed warning, Warnings, Adverse reactions | Desvenlafaxine |
| Desvenlafaxine | DESVENLAFAXINE | American Health Packaging | e0dbbdbc-9438-407a-b3e1-f3bb7f177a4e | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | Desvenlafaxine |
| Desvenlafaxine | DESVENLAFAXINE | Actavis Pharma, Inc. | 617476f9-62d7-40ef-a1b1-c349d4ad706f | 2024-04-01 | Boxed warning, Warnings, Adverse reactions | Desvenlafaxine |
| Desvenlafaxine | DESVENLAFAXINE SUCCINATE | A-S Medication Solutions | 88ac1206-864b-47a3-82ab-be83bc9532f3 | 2023-09-19 | Boxed warning, Warnings, Adverse reactions | Desvenlafaxine |
| Desvenlafaxine | DESVENLAFAXINE | Sun Pharmaceutical Industries, Inc. | 91cf39c9-4d26-480a-a3a3-a3d8d4c4d222 | 2023-08-07 | Boxed warning, Warnings, Adverse reactions | Desvenlafaxine |
| Desvenlafaxine | DESVENLAFAXINE SUCCINATE | A-S Medication Solutions | b2a3edb8-ba64-4ead-b452-d6c8dbaba91d | 2023-02-17 | Boxed warning, Warnings, Adverse reactions | Desvenlafaxine |
| Desvenlafaxine | DESVENLAFAXINE SUCCINATE | Proficient Rx LP | d4542c5e-f9e8-49c7-afa6-9dd4c4d485f2 | 2023-02-01 | Boxed warning, Warnings, Adverse reactions | Desvenlafaxine |
| Desvenlafaxine | DESVENLAFAXINE SUCCINATE | Alembic Pharmaceuticals Limited | 5bd203d2-477e-4d12-a875-cb8009f42410 | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | Desvenlafaxine |
| Desvenlafaxine | DESVENLAFAXINE | Alembic Pharmaceuticals Limited | 9f74708c-6f6a-46cf-8c79-87a25c2bb6f8 | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | Desvenlafaxine |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75239 | SUPPL | 2023-08-22 |
| 75235 | SUPPL | 2023-08-22 |
| 75223 | SUPPL | 2023-08-22 |
| 61237 | SUPPL | 2019-12-11 |
| 61236 | SUPPL | 2019-12-11 |
| 61231 | SUPPL | 2019-12-11 |
| 50900 | SUPPL | 2017-12-27 |
| 50798 | SUPPL | 2017-12-21 |
| 46771 | SUPPL | 2017-01-10 |
| 46714 | SUPPL | 2017-01-06 |
| 44924 | ORIG | 2014-10-10 |
| 22995 | ORIG | 2014-10-10 |
| 40484 | SUPPL | 2014-07-23 |
| 32692 | SUPPL | 2014-07-23 |
| 32691 | SUPPL | 2014-07-23 |
| 19662 | SUPPL | 2014-07-23 |
| 19661 | ORIG | 2014-01-31 |
| 10470 | ORIG | 2014-01-29 |