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 HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Alembic Pharmaceuticals Limited | e3e238db-4388-49bb-aa67-6d73adbb2280 | 2024-06-11 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE |
| venlafaxine hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 6cb943a8-5972-292f-e053-2991aa0ae3ee | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | 19b1543e-d599-a869-e063-6294a90a8e28 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | bff505db-2752-41fc-a4dd-4773f629106e | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 04340ccb-c3b3-41ab-a4bc-101d8b6bc1a9 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | QUALLENT PHARMACEUTICALS HEALTH LLC | cb4c04a6-47d1-44ff-8d58-718102fa08eb | 2024-05-24 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 304bda24-9151-47b5-9f62-005ea325a11e | 2024-05-23 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Aurobindo Pharma Limited | 85d3ce8b-8966-45d9-bdaf-f6f0475096e1 | 2024-04-26 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 1a9e207a-aba5-4ecb-b7b6-7c1e38be5ac9 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 9a30e1b5-272b-4109-ad6c-a3c9a895822f | 2024-03-09 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | df7e0982-3eb0-4bdf-8f7f-4f4a48476ed7 | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Proficient Rx LP | 5c558ab8-b4b3-4973-b016-ed5cfcb4d88b | 2023-11-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 49e5833b-4693-45b5-9abb-1b369eb4086d | 2023-10-25 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| venlafaxine hydrochloride | VENLAFAXINE HYDROCHLORIDE | Zydus Lifesciences Limited | 1be1be3a-304b-4e31-8732-335247029191 | 2023-09-28 | venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE | |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | dc989aa7-c4ab-4359-a971-523eb477ef9b | 2023-09-15 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | e1114c1d-c193-4c0c-ad1c-c17b3fc61723 | 2023-09-14 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 37aaa8ac-4e0c-4e04-98b5-19b0d90d857c | 2023-08-25 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine | VENLAFAXINE HYDROCHLORIDE | Aurobindo Pharma Limited | b23637e5-d37f-41b5-ba76-fc053e903bc2 | 2023-08-21 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 20319949-ccf9-477a-a6e3-53502772deb9 | 2023-08-19 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Effexor XR | VENLAFAXINE HYDROCHLORIDE | Viatris Specialty LLC | c848a5d8-ba94-4c84-80e3-0bf35fb8e32e | 2023-08-15 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |