Application 090899
- Type
- ANDA
- Sponsor
- TORRENT PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 37.5MG BASE | No | No |
| 002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 75MG BASE | No | No |
| 003 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 150MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090899-001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | ||
| A090899-002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | ||
| A090899-003 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 |
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 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090899-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090899-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090899-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090899-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090899-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090899-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090899-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090899-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090899-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090899-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090899-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090899-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090899-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090899-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090899-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090899-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090899-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090899-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090899-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090899-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090899-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090899-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090899-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090899-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090899-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090899-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090899-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 2011-06-01 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090899-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090899-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090899-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090899-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090899-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090899-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090899-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090899-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090899-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090899-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090899-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090899-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090899-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090899-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090899-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090899-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090899-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090899-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090899-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090899-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090899-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090899-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090899-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090899-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090899-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090899-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090899-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090899-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090899-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090899-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090899-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090899-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090899-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090899-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090899-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090899-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090899-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090899-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090899-003 | AB | 1 | ea99ee380514… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090899-001 | AB | 1 | a67488948f0b… |
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 |
|---|---|---|---|---|---|---|
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Coupler LLC | 4a007068-89d9-c296-e063-6394a90ad6d0 | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 85740bf6-7e88-4a6e-9ec9-3455e3b95e59 | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | ea5914ab-28f3-4cb3-bade-6eaccac214e4 | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | bce7adf8-b4b5-4d7f-bf0d-ae1277ae3a2b | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | QPharma, Inc. | 4992698e-5d5a-6468-e063-6394a90ab404 | 2026-02-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | b19ec628-4034-4316-ad3d-46c1ee220728 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 806b3e38-3b2a-4aaa-973c-e2d921bb353e | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | c4312b7b-7a42-45f1-b6e6-e20ea76020c4 | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | e2d5a2d5-5e55-426c-bc8d-d29729eba775 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | AvKARE | 7f224c88-9425-9ef0-01bc-dcf3bdafbd89 | 2026-01-16 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 9fda0f8d-b24e-4581-9dca-7aaaf86e2413 | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | Northwind Health Company, LLC | f2b5c729-17c8-7ecc-e053-2a95a90a2e53 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | Northwind Health Company, LLC | fb076577-b9da-c78b-e053-6394a90a107b | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Northwind Health Company, LLC | f757cac4-efa7-668c-e053-6294a90a720d | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine hydrochloride | VENLAFAXINE HYDROCHLORIDE | Chartwell RX, LLC | 85ec2d3f-49e4-4ac5-bd4a-c227589dbf58 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | QPharma, Inc. | 9e745ad7-be4f-4369-be23-587e1154e4ab | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | 0a1b6bcd-8d46-44ab-bc5d-65515601d2ff | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | 349308ef-2caf-4fec-b428-56ae06c6771d | 2025-11-25 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Major Pharmaceuticals | d962f5af-7642-4c6e-b7be-3e089fe48873 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 22980b32-cbae-4f37-9fc0-b47221b2c32e | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
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 |
|---|---|---|---|---|---|
| 0904-6468 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6468 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6469 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6469 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6470 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6470 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 13668-018 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-018 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-018 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-018 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-018 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-018 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-018 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-019 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-019 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-019 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-019 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-019 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-019 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-019 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-020 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-020 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-020 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-020 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-020 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-020 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-020 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 50090-3084 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3855 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3855 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 55154-3362 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-3362 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Cardinal Health | ANDA | Current |
| 55700-518 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-518 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-518 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-518 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-518 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-519 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-519 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-519 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-520 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-520 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-520 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-520 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-520 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Lake Erie Medical DBA Qua | ANDA | Current |
| 68071-1579 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68788-8917 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71335-1344 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1344 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1344 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1344 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1344 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1509 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1509 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1509 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1509 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 80425-0088 | Effexor XR | Venlafaxine HCl 150mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0088 | Venlafaxine HCL | Venlafaxine HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0088 | Venlafaxine HCL | Venlafaxine HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0088 | Venlafaxine HCL | Venlafaxine HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |