Application 214423
- Type
- ANDA
- Sponsor
- PHARMADAX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 75MG BASE | No | No |
| 002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214423-001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | ||
| A214423-002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 |
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 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2022-01-04 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-01-04 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-01-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-01-04 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-01-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-01-04 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-01-04 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A214423-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-01-04 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A214423-002 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-01-04 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214423-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214423-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A214423-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A214423-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A214423-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A214423-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A214423-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A214423-002 | AB | 1 | bb7c543d1eb4… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214423-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214423-002 | AB | 1 | cb3db0bc1861… |
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. | 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 |
| 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 | 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.