Application 200834
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
|---|---|---|---|---|---|---|---|
| A200834-001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | |
| A200834-002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | |
| A200834-003 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200834-001 | AB |
| A200834-002 | AB |
| A200834-003 | AB |
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 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A200834-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200834-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200834-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A200834-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200834-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200834-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A200834-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200834-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200834-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200834-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200834-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200834-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200834-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200834-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200834-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200834-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200834-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200834-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200834-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200834-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200834-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200834-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200834-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200834-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200834-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200834-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200834-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200834-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200834-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200834-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200834-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200834-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200834-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200834-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200834-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200834-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200834-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200834-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200834-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200834-001 | AB | 1 | 301d65b070ca… |
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 | NuCare Pharmaceuticals, Inc. | 3cbe3e18-9a7e-aaa3-e063-6394a90abf92 | 2025-08-19 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | American Health Packaging | e05bdeb4-07a9-441e-901b-f2aea550db2b | 2025-06-24 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 68084-709 68084-713 68084-698 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 35d3148b-52f3-197c-e063-6294a90a44e3 | 2025-05-23 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine HCL ER | VENLAFAXINE HCL ER | Direct_Rx | e20b7d9e-f755-4325-e053-2995a90ac45d | 2025-01-22 | Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine hydrochloride ER | VENLAFAXINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f8fd4381-52f2-d9c1-e053-6394a90a08e5 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine hydrochloride ER | VENLAFAXINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f89bcae0-e714-599a-e053-6294a90a2c3a | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8906ed5a-f69c-0eac-e053-2995a90ae600 | 2024-11-20 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 68071-4897 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 9d38eac0-9d64-1274-e053-2995a90a189a | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 68071-5160 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8f9d3d30-e9a6-6c85-e053-2a95a90a5524 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 68071-5020 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | bff505db-2752-41fc-a4dd-4773f629106e | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 04340ccb-c3b3-41ab-a4bc-101d8b6bc1a9 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | QUALLENT PHARMACEUTICALS HEALTH LLC | cb4c04a6-47d1-44ff-8d58-718102fa08eb | 2024-05-24 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Aurobindo Pharma Limited | 85d3ce8b-8966-45d9-bdaf-f6f0475096e1 | 2024-04-26 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 65862-697 65862-527 65862-528 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 1a9e207a-aba5-4ecb-b7b6-7c1e38be5ac9 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Proficient Rx LP | 5c558ab8-b4b3-4973-b016-ed5cfcb4d88b | 2023-11-01 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | e1114c1d-c193-4c0c-ad1c-c17b3fc61723 | 2023-09-14 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Proficient Rx LP | aaa14e95-904e-45c6-be4d-c94167b20300 | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Proficient Rx LP | 18e77a42-6552-4042-9ed3-046c94f4f921 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
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 |
|---|---|---|---|---|---|
| 0179-0161 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-0162 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 43353-233 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-234 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-268 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-2180 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2180 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2180 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2180 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2281 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2281 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2281 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2281 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2519 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2519 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2519 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4568 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-0528 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Unit Dose Services | ANDA | Current |
| 52343-131 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-131 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-131 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-131 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-131 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-131 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-132 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-132 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-132 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-132 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-132 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-132 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-133 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-133 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-133 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-133 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-133 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-133 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 53002-2361 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2365 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2366 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-887 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-887 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-887 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 65862-527 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-527 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-527 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-527 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-527 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-527 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-527 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-528 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-528 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-528 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-528 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-528 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-528 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-528 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-697 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-697 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-697 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-697 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-697 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-697 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-697 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 67046-320 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-406 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 68071-4897 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4897 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5020 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5020 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5160 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5160 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-698 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-698 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-698 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-698 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-709 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-709 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-709 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-709 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-713 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | American Health Packaging | ANDA | Current |