Application 217841
- Type
- ANDA
- Sponsor
- ABON PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | No | No |
| 002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217841-001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 | |
| A217841-002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217841-001 | AB |
| A217841-002 | 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 | A217841-001 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217841-002 | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217841-001 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217841-002 | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217841-001 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217841-002 | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217841-001 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217841-002 | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217841-001 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217841-002 | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 | b8a1b40f171c… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217841-001 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217841-002 | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-02-07 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217841-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217841-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217841-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217841-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217841-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217841-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217841-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217841-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217841-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217841-002 | AB | 1 | b8a1b40f171c… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217841-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217841-002 | AB | 1 | a50c72e98297… |
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 | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | b19ec628-4034-4316-ad3d-46c1ee220728 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 806b3e38-3b2a-4aaa-973c-e2d921bb353e | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | c4312b7b-7a42-45f1-b6e6-e20ea76020c4 | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | e2d5a2d5-5e55-426c-bc8d-d29729eba775 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | c41d847b-88ba-49a5-9d73-269ac4caa4ed | 2026-01-16 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | AvKARE | 7f224c88-9425-9ef0-01bc-dcf3bdafbd89 | 2026-01-16 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 9fda0f8d-b24e-4581-9dca-7aaaf86e2413 | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | Northwind Health Company, LLC | f2b5c729-17c8-7ecc-e053-2a95a90a2e53 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | Northwind Health Company, LLC | fb076577-b9da-c78b-e053-6394a90a107b | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Northwind Health Company, LLC | f757cac4-efa7-668c-e053-6294a90a720d | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine hydrochloride | VENLAFAXINE HYDROCHLORIDE | Chartwell RX, LLC | 85ec2d3f-49e4-4ac5-bd4a-c227589dbf58 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | QPharma, Inc. | 9e745ad7-be4f-4369-be23-587e1154e4ab | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | 0a1b6bcd-8d46-44ab-bc5d-65515601d2ff | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | 349308ef-2caf-4fec-b428-56ae06c6771d | 2025-11-25 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Major Pharmaceuticals | d962f5af-7642-4c6e-b7be-3e089fe48873 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 22980b32-cbae-4f37-9fc0-b47221b2c32e | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | b18d726e-cdb2-4c80-a49d-330cddee17e9 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 6c1d0d4f-c8e2-4035-8f4e-7a46bfe3f059 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | b055df74-51f9-401f-8cca-24269a0163df | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 0c404290-2806-4756-bca3-2d639b400963 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |