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 ER | VENLAFAXINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f8fd4381-52f2-d9c1-e053-6394a90a08e5 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride ER | VENLAFAXINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f7a9741b-2dd3-d8f3-e053-6294a90a4d73 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine hydrochloride ER | VENLAFAXINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f89bcae0-e714-599a-e053-6294a90a2c3a | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 2a85bd43-419c-6ed7-e063-6294a90a84d4 | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Advagen Pharma Ltd. | 48a75840-64e4-4d44-9a62-009373003105 | 2024-12-09 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals Inc. | 2787aaa2-5210-f7d5-e063-6294a90a7103 | 2024-11-22 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8906ed5a-f69c-0eac-e053-2995a90ae600 | 2024-11-20 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 20a7d922-7f7c-4de4-b5fd-55c13aab060c | 2024-10-31 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Proficient Rx LP | 9f697c00-f5ec-454a-a66c-503aef5fc609 | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Proficient Rx LP | 613658d3-7eb5-4822-961f-f4c6f6b2a2c1 | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Proficient Rx LP | adeba7dd-bd15-4d8f-b703-24c3a208e740 | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | baae24d6-e425-4cfc-9a53-3cd223b6d344 | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 1e1119f7-0c2e-4587-a24d-0066f73b2e65 | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Zydus Lifesciences Limited | 51334651-7a7f-4653-bf9d-d5be04fd902d | 2024-08-14 | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE | |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 0ee91447-2c23-4519-81cc-550b5416dd6b | 2024-08-05 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 1e04fe02-88c9-dafd-e063-6294a90ac4c9 | 2024-07-24 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 1bf78b22-a0e3-5f9f-e063-6394a90a3024 | 2024-06-28 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 9d38eac0-9d64-1274-e053-2995a90a189a | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8f9d3d30-e9a6-6c85-e053-2a95a90a5524 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 9c061460-3b80-41e1-a87a-1a25108ff740 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |