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 | Alembic Pharmaceuticals Limited | e3e238db-4388-49bb-aa67-6d73adbb2280 | 2024-06-11 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE |
| venlafaxine hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 6cb943a8-5972-292f-e053-2991aa0ae3ee | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | 19b1543e-d599-a869-e063-6294a90a8e28 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | bff505db-2752-41fc-a4dd-4773f629106e | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 04340ccb-c3b3-41ab-a4bc-101d8b6bc1a9 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | QUALLENT PHARMACEUTICALS HEALTH LLC | cb4c04a6-47d1-44ff-8d58-718102fa08eb | 2024-05-24 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 304bda24-9151-47b5-9f62-005ea325a11e | 2024-05-23 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Aurobindo Pharma Limited | 85d3ce8b-8966-45d9-bdaf-f6f0475096e1 | 2024-04-26 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 1a9e207a-aba5-4ecb-b7b6-7c1e38be5ac9 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 9a30e1b5-272b-4109-ad6c-a3c9a895822f | 2024-03-09 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | df7e0982-3eb0-4bdf-8f7f-4f4a48476ed7 | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Proficient Rx LP | 5c558ab8-b4b3-4973-b016-ed5cfcb4d88b | 2023-11-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 49e5833b-4693-45b5-9abb-1b369eb4086d | 2023-10-25 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| venlafaxine hydrochloride | VENLAFAXINE HYDROCHLORIDE | Zydus Lifesciences Limited | 1be1be3a-304b-4e31-8732-335247029191 | 2023-09-28 | venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE | |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | dc989aa7-c4ab-4359-a971-523eb477ef9b | 2023-09-15 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | e1114c1d-c193-4c0c-ad1c-c17b3fc61723 | 2023-09-14 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 37aaa8ac-4e0c-4e04-98b5-19b0d90d857c | 2023-08-25 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine | VENLAFAXINE HYDROCHLORIDE | Aurobindo Pharma Limited | b23637e5-d37f-41b5-ba76-fc053e903bc2 | 2023-08-21 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 20319949-ccf9-477a-a6e3-53502772deb9 | 2023-08-19 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Effexor XR | VENLAFAXINE HYDROCHLORIDE | Viatris Specialty LLC | c848a5d8-ba94-4c84-80e3-0bf35fb8e32e | 2023-08-15 | Boxed warning, Warnings, Adverse reactions | 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 |