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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200834-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200834-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A200834-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200834-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200834-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200834-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200834-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200834-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A200834-001 | AB | 1 | 8072bd15b7f6… |
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 | REMEDYREPACK INC. | 4e3053b9-cdec-4f4d-85ae-2e55cf1cc185 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 50d3b487-9f65-4e2f-b6eb-9533964f8972 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | ac9b972d-8b8a-4727-90c2-b208f91272fd | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Coupler LLC | 5358f20f-b864-0aae-e063-6394a90a7eab | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Coupler LLC | 5359012e-a868-3aa3-e063-6294a90a74e2 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Asclemed USA, Inc. | c69d16fd-b82d-4708-aece-ab4f60b29cc6 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | 7852be9e-0c1d-47a8-9513-c3a04b365763 | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 50090-2281 50090-2180 50090-2519 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | 28c8f404-1dbd-4140-8959-32624d7c7724 | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | 296d6ab7-8c0c-40e5-8cb2-9d125b42b8bb | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Cardinal Health 107, LLC | 7588ffdc-034d-4baf-9889-9a0ded265be5 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | 33068acd-d361-4cd9-b994-02a7865ff04f | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | 812ca864-8230-4c84-a7f4-d1b926dee31a | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | 569e10d1-6432-473c-a026-ac438bd77bcd | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine HCL ER | VENLAFAXINE HCL ER | Direct_Rx | f32ca617-66e0-41d8-e053-2a95a90ae40a | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | QPharma, Inc. | 4992698e-5d5a-6468-e063-6394a90ab404 | 2026-02-01 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | e2d5a2d5-5e55-426c-bc8d-d29729eba775 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Northwind Health Company, LLC | f757cac4-efa7-668c-e053-6294a90a720d | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Major Pharmaceuticals | d962f5af-7642-4c6e-b7be-3e089fe48873 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 22980b32-cbae-4f37-9fc0-b47221b2c32e | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 0c404290-2806-4756-bca3-2d639b400963 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 200834 ANDA200834 |
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 |