Application 079098
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE | No | No |
| 002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET;ORAL | EQ 37.5MG BASE | No | No |
| 003 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 004 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET;ORAL | EQ 75MG BASE | No | No |
| 005 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079098-001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2010-05-11 | ||
| A079098-002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET / ORAL | 2010-05-11 | ||
| A079098-003 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2010-05-11 | ||
| A079098-004 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2010-05-11 | ||
| A079098-005 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2010-05-11 |
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 | A079098-001 | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2010-05-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A079098-002 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET / ORAL | 2010-05-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A079098-003 | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2010-05-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A079098-004 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2010-05-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A079098-005 | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2010-05-11 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079098-001 | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2010-05-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079098-002 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET / ORAL | 2010-05-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079098-003 | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2010-05-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079098-004 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2010-05-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079098-005 | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2010-05-11 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079098-001 | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2010-05-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079098-002 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET / ORAL | 2010-05-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079098-003 | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2010-05-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079098-004 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2010-05-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079098-005 | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2010-05-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079098-001 | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2010-05-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079098-002 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET / ORAL | 2010-05-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079098-003 | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2010-05-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079098-004 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2010-05-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079098-005 | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2010-05-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079098-001 | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2010-05-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079098-002 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET / ORAL | 2010-05-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079098-003 | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2010-05-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079098-004 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2010-05-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079098-005 | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2010-05-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079098-001 | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2010-05-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079098-002 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET / ORAL | 2010-05-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079098-003 | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2010-05-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079098-004 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2010-05-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079098-005 | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2010-05-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079098-001 | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2010-05-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079098-002 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET / ORAL | 2010-05-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079098-003 | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2010-05-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079098-004 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2010-05-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079098-005 | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2010-05-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079098-001 | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2010-05-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079098-002 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET / ORAL | 2010-05-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079098-003 | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2010-05-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079098-004 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2010-05-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079098-005 | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2010-05-11 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079098-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079098-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079098-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079098-004 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079098-005 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A079098-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A079098-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A079098-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A079098-004 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A079098-005 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079098-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079098-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079098-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079098-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079098-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A079098-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A079098-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A079098-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A079098-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A079098-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A079098-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A079098-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A079098-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A079098-004 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A079098-005 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A079098-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079098-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079098-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079098-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079098-005 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A079098-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A079098-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A079098-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A079098-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A079098-005 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A079098-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A079098-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A079098-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A079098-004 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A079098-005 | AB | 1 | 782e0a99824c… |
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. | c41d847b-88ba-49a5-9d73-269ac4caa4ed | 2026-09-03 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 963e5599-f9af-45c2-8cf4-13cf52eed6a0 | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE | REMEDYREPACK INC. | 9df3a51c-1b89-4d2a-8f41-3755910e9bfb | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 33b39416-7981-46fb-ba31-e933a6afcf8b | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Advagen Pharma Ltd. | 48a75840-64e4-4d44-9a62-009373003105 | 2026-08-25 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE |
| 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 |
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 |
|---|---|---|---|---|---|
| 42291-892 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-892 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | AvKARE | ANDA | Current |
| 42291-893 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-893 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | AvKARE | ANDA | Current |
| 42291-894 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-894 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | AvKARE | ANDA | Current |
| 42291-895 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-895 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | AvKARE | ANDA | Current |
| 42291-896 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-896 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | AvKARE | ANDA | Current |
| 43353-798 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-798 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-798 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-802 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50268-798 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-798 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-798 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-798 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-799 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-799 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-799 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-799 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-800 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-800 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-800 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-800 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-801 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-801 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-801 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-801 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-802 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-802 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 50268-802 | Venlafaxine Hydrochloride | Venlafaxine | AvPAK | ANDA | Current |
| 63629-3323 | Venlafaxine Hydrochloride | Venlafaxine | Bryant Ranch Prepack | ANDA | Current |
| 65162-300 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-300 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-300 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-300 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-302 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-302 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-302 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-302 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-305 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-305 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-305 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-305 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-306 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-306 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-306 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-306 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-307 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-307 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-307 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-307 | Venlafaxine Hydrochloride | Venlafaxine | Amneal Pharmaceuticals LLC | ANDA | Current |