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 | Preferred Pharmaceuticals Inc. | de6e30f8-c8ef-4016-b228-0f188645347b | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 92b3f73d-d6ca-4d7d-9035-5700f527cb85 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 653f3f95-98d0-4ce0-bf10-ac7938be690e | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 33b39416-7981-46fb-ba31-e933a6afcf8b | 2025-09-26 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE | REMEDYREPACK INC. | 9df3a51c-1b89-4d2a-8f41-3755910e9bfb | 2025-09-25 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 963e5599-f9af-45c2-8cf4-13cf52eed6a0 | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 3cbe3e18-9a7e-aaa3-e063-6394a90abf92 | 2025-08-19 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Marlex Pharmaceuticals, Inc. | 3c2e188f-76aa-a022-e063-6294a90abfc9 | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Trigen Laboratories, LLC | fdaed1c2-dd0a-4bf3-975a-86fe3e7f0c97 | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | 5c943206-6df8-4fc5-ab1d-d34b9715182c | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | American Health Packaging | e05bdeb4-07a9-441e-901b-f2aea550db2b | 2025-06-24 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 35d3148b-52f3-197c-e063-6294a90a44e3 | 2025-05-23 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE | Rising Pharma Holdings, Inc. | 074f4478-e81b-45a2-ae85-ffd27bed940f | 2025-04-03 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride |
| venlafaxine hydrochloride | VENLAFAXINE HYDROCHLORIDE | Dr.Reddys Laboratories Inc | f5c21429-d5d0-9f93-a465-6e5e0e19ebdd | 2025-03-26 | Boxed warning, Warnings, Adverse reactions | venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 15c77ad7-7edc-4c36-ba3f-3ef05dfb12dc | 2025-02-27 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | AvPAK | 2efde38c-250e-d1b9-e063-6394a90a1b74 | 2025-02-25 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE | Preferred Pharmaceuticals Inc. | edefc932-d25d-4ead-b348-b3b6d9232091 | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 2cf6e6ad-7d00-0db1-e063-6394a90ab1ec | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 2c2bb0e6-5a73-ff57-e063-6294a90a88d3 | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE | BluePoint Laboratories | 5efe1336-c796-4560-8110-a64c80eefb0c | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |