Application 078865
- Type
- ANDA
- Sponsor
- WOCKHARDT
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 |
|---|---|---|---|---|---|---|---|
| A078865-001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | |
| A078865-002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | |
| A078865-003 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078865-001 | AB |
| A078865-002 | AB |
| A078865-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078865-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078865-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078865-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078865-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078865-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078865-003 | 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 | A078865-001 | 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 | A078865-002 | 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 | A078865-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078865-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078865-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078865-003 | 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 | A078865-001 | 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 | A078865-002 | 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 | A078865-003 | 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 | A078865-001 | 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 | A078865-002 | 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 | A078865-003 | 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 | A078865-001 | 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 | A078865-002 | 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 | A078865-003 | 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 | A078865-001 | 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 | A078865-002 | 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 | A078865-003 | 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 | A078865-001 | 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 | A078865-002 | 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 | A078865-003 | 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 | A078865-001 | 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 | A078865-002 | 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 | A078865-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078865-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078865-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078865-003 | 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 | A078865-001 | 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 | A078865-002 | 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 | A078865-003 | 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 | A078865-001 | 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 | A078865-002 | 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 | A078865-003 | 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 | A078865-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078865-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078865-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078865-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078865-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078865-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078865-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078865-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078865-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078865-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078865-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078865-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078865-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078865-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078865-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078865-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078865-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078865-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078865-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078865-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078865-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078865-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078865-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078865-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078865-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078865-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078865-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078865-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078865-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078865-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078865-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078865-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078865-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078865-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078865-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078865-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078865-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078865-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078865-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078865-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078865-001 | AB | 1 | 1e350fbaab3a… |
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 3eef522f-9e95-4668-bb12-09fd47ed0daf | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | b1d21366-f686-4e20-a10f-0c25f517db38 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | f56a0f70-bbb1-4e69-b969-965a72f0e2f0 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 4e3053b9-cdec-4f4d-85ae-2e55cf1cc185 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 50d3b487-9f65-4e2f-b6eb-9533964f8972 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | ac9b972d-8b8a-4727-90c2-b208f91272fd | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Yaopharma Co., Ltd. | 38fd2c97-cd30-2f7d-e054-00144ff8d46c | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 4a82cef5-693e-46e9-90c4-bff753cdce37 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | f50029b8-7d05-445a-9d9f-71a1aee6088b | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | 5a990dbd-f280-4caf-b950-4703ee98b230 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | d94e5404-f728-4e4b-af99-8a8e4dfae227 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | c37a73fa-ceee-4555-a61b-e1e66ad6e97d | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 7fcd7995-81fb-4368-bd4c-3726b2ae363e | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | Coupler LLC | 53e5c5a2-b8e7-3d75-e063-6294a90a508b | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Coupler LLC | 5358f20f-b864-0aae-e063-6394a90a7eab | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Coupler LLC | 5359012e-a868-3aa3-e063-6294a90a74e2 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | NorthStar RxLLC | b865c175-e75d-4cb4-ac29-dec72226302c | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine hydrochloride | VENLAFAXINE HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 3e51f786-3691-4ec4-836b-7f2c9a385aa7 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | Venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Asclemed USA, Inc. | c69d16fd-b82d-4708-aece-ab4f60b29cc6 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 7aa3edba-4248-49bb-86f7-06fdbf2a6fb7 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6246 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Major Pharmaceuticals | ANDA | Current |
| 55648-716 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Wockhardt Limited | ANDA | Current |
| 55648-717 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Wockhardt Limited | ANDA | Current |
| 55648-718 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Wockhardt Limited | ANDA | Current |
| 63739-633 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | McKesson Corporation | ANDA | Current |
| 63739-633 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-633 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 64679-716 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 64679-716 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 64679-716 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 64679-717 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 64679-717 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 64679-717 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 64679-718 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 64679-718 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 64679-718 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |