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 | BluePoint Laboratories | 5efe1336-c796-4560-8110-a64c80eefb0c | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine hydrochloride ER | VENLAFAXINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f8fd4381-52f2-d9c1-e053-6394a90a08e5 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride ER | VENLAFAXINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f7a9741b-2dd3-d8f3-e053-6294a90a4d73 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine hydrochloride ER | VENLAFAXINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f89bcae0-e714-599a-e053-6294a90a2c3a | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 2a85bd43-419c-6ed7-e063-6294a90a84d4 | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals Inc. | 2787aaa2-5210-f7d5-e063-6294a90a7103 | 2024-11-22 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8906ed5a-f69c-0eac-e053-2995a90ae600 | 2024-11-20 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 20a7d922-7f7c-4de4-b5fd-55c13aab060c | 2024-10-31 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Proficient Rx LP | 9f697c00-f5ec-454a-a66c-503aef5fc609 | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Proficient Rx LP | 613658d3-7eb5-4822-961f-f4c6f6b2a2c1 | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Proficient Rx LP | adeba7dd-bd15-4d8f-b703-24c3a208e740 | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | baae24d6-e425-4cfc-9a53-3cd223b6d344 | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 1e1119f7-0c2e-4587-a24d-0066f73b2e65 | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Zydus Lifesciences Limited | 51334651-7a7f-4653-bf9d-d5be04fd902d | 2024-08-14 | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE | |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 0ee91447-2c23-4519-81cc-550b5416dd6b | 2024-08-05 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 1e04fe02-88c9-dafd-e063-6294a90ac4c9 | 2024-07-24 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 1bf78b22-a0e3-5f9f-e063-6394a90a3024 | 2024-06-28 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 9d38eac0-9d64-1274-e053-2995a90a189a | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8f9d3d30-e9a6-6c85-e053-2a95a90a5524 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 9c061460-3b80-41e1-a87a-1a25108ff740 | 2024-06-19 | 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 |