Application 020699
- Type
- NDA
- Sponsor
- WYETH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 37.5MG BASE | Yes | No |
| 002 | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 75MG BASE | Yes | No |
| 003 | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 100MG BASE | No | No |
| 004 | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020699-001 | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 |
| N020699-002 | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 |
| N020699-003 | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1997-10-20 | |
| N020699-004 | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1997-10-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020699-001 | AB |
| N020699-002 | AB |
| N020699-004 | 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 | N020699-001 | EFFEXOR XR | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020699-002 | EFFEXOR XR | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020699-003 | EFFEXOR XR | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1997-10-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020699-004 | EFFEXOR XR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1997-10-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020699-001 | EFFEXOR XR | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020699-002 | EFFEXOR XR | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020699-003 | EFFEXOR XR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 1997-10-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020699-004 | EFFEXOR XR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1997-10-20 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020699-001 | EFFEXOR XR | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020699-002 | EFFEXOR XR | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020699-003 | EFFEXOR XR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 1997-10-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020699-004 | EFFEXOR XR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1997-10-20 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020699-001 | EFFEXOR XR | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020699-002 | EFFEXOR XR | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020699-003 | EFFEXOR XR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 1997-10-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020699-004 | EFFEXOR XR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1997-10-20 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020699-001 | EFFEXOR XR | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020699-002 | EFFEXOR XR | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020699-003 | EFFEXOR XR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 1997-10-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020699-004 | EFFEXOR XR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1997-10-20 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020699-001 | EFFEXOR XR | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020699-002 | EFFEXOR XR | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020699-003 | EFFEXOR XR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 1997-10-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020699-004 | EFFEXOR XR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1997-10-20 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020699-001 | EFFEXOR XR | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020699-002 | EFFEXOR XR | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020699-003 | EFFEXOR XR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 1997-10-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020699-004 | EFFEXOR XR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1997-10-20 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020699-001 | EFFEXOR XR | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020699-002 | EFFEXOR XR | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020699-003 | EFFEXOR XR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 1997-10-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020699-004 | EFFEXOR XR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1997-10-20 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020699-001 | EFFEXOR XR | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020699-002 | EFFEXOR XR | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020699-003 | EFFEXOR XR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 1997-10-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020699-004 | EFFEXOR XR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1997-10-20 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020699-001 | EFFEXOR XR | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020699-002 | EFFEXOR XR | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1997-10-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020699-003 | EFFEXOR XR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | 1997-10-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020699-004 | EFFEXOR XR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1997-10-20 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020699-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020699-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020699-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020699-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020699-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020699-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020699-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020699-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020699-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020699-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020699-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020699-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020699-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020699-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020699-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020699-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020699-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020699-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020699-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020699-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020699-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020699-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020699-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020699-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020699-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020699-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020699-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020699-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020699-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020699-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020699-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020699-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020699-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020699-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020699-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020699-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020699-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020699-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020699-004 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020699-001 | AB | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| Effexor XR | VENLAFAXINE HYDROCHLORIDE | Viatris Specialty LLC | c848a5d8-ba94-4c84-80e3-0bf35fb8e32e | 2023-08-15 | Boxed warning, Warnings, Adverse reactions | 020699 NDA020699 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0008-0833 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0833 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0833 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0833 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0833 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0833 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0836 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0836 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0836 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0836 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0836 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0836 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0837 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0837 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0837 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0837 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0837 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0837 | Effexor | VENLAFAXINE HYDROCHLORIDE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 21695-045 | Effexor | venlafaxine hydrochloride | Rebel Distributors Corp | NDA | Current |
| 21695-046 | Effexor | venlafaxine hydrochloride | Rebel Distributors Corp | NDA | Current |
| 21695-047 | Effexor | venlafaxine hydrochloride | Rebel Distributors Corp | NDA | Current |
| 21695-957 | Venlafaxine Hydrochloride | venlafaxine hydrochloride | Rebel Distributors Corp | NDA | Current |
| 21695-958 | Venlafaxine Hydrochloride | venlafaxine hydrochloride | Rebel Distributors Corp | NDA | Current |
| 21695-961 | Venlafaxine Hydrochloride | venlafaxine hydrochloride | Rebel Distributors Corp | NDA | Current |
| 45865-643 | Venlafaxine Hydrochloride | venlafaxine hydrochloride | Medsource Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 45865-643 | Venlafaxine Hydrochloride | venlafaxine hydrochloride | Medsource Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 45865-647 | Venlafaxine Hydrochloride | venlafaxine hydrochloride | Medsource Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 45865-647 | Venlafaxine Hydrochloride | venlafaxine hydrochloride | Medsource Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 55289-277 | Effexor | VENLAFAXINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, In | NDA | Current |
| 55289-277 | Effexor | VENLAFAXINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-277 | Effexor | VENLAFAXINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-277 | Effexor | VENLAFAXINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-277 | Effexor | VENLAFAXINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 59762-0180 | Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0181 | Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0182 | Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 61919-848 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | DIRECT RX | NDA | Current |
| 61919-848 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | DIRECT RX | NDA | Current |
| 61919-920 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | DIRECT RX | NDA AUTHORIZED GENERIC | Current |
| 63187-223 | Venlafaxine Hydrochloride | venlafaxine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-224 | Venlafaxine Hydrochloride | venlafaxine hydrochloride | Proficient Rx LP | ANDA | Current |
| 67544-189 | Effexor | venlafaxine hydrochloride | Aphena Pharma Solutions - Tennessee, Inc. | NDA | Current |
| 68151-3659 | Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Carilion Materials Management | NDA AUTHORIZED GENERIC | Current |
| 68151-3660 | Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Carilion Materials Management | NDA AUTHORIZED GENERIC | Current |
| 70518-2156 | Effexor | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | NDA | Current |
| 70518-2157 | Effexor | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | NDA | Current |
| 71610-013 | Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Aphena Pharma Solutions - | NDA AUTHORIZED | Current |
| 71610-013 | Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 71610-018 | Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Aphena Pharma Solutions - | NDA AUTHORIZED | Current |
| 71610-018 | Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75255 | SUPPL | 2023-08-22 |
| 75170 | SUPPL | 2023-08-21 |
| 75160 | SUPPL | 2023-08-21 |
| 71827 | SUPPL | 2022-08-17 |
| 71826 | SUPPL | 2022-08-17 |
| 71809 | SUPPL | 2022-08-16 |
| 69302 | SUPPL | 2021-11-12 |
| 69301 | SUPPL | 2021-11-12 |
| 69299 | SUPPL | 2021-11-12 |
| 68711 | SUPPL | 2021-09-21 |
| 68710 | SUPPL | 2021-09-21 |
| 68679 | SUPPL | 2021-09-21 |
| 50892 | SUPPL | 2017-12-27 |
| 50814 | SUPPL | 2017-12-21 |
| 50812 | SUPPL | 2017-12-21 |
| 50811 | SUPPL | 2017-12-21 |
| 50891 | SUPPL | 2017-12-20 |
| 47827 | SUPPL | 2017-04-03 |
| 47778 | SUPPL | 2017-03-30 |
| 46741 | SUPPL | 2017-01-10 |
| 46688 | SUPPL | 2017-01-06 |
| 13239 | SUPPL | 2016-03-03 |
| 3118 | SUPPL | 2016-03-02 |
| 25555 | SUPPL | 2014-12-19 |
| 13234 | SUPPL | 2014-12-19 |
| 25560 | SUPPL | 2014-10-23 |
| 25561 | SUPPL | 2014-07-09 |
| 25559 | SUPPL | 2014-07-09 |
| 35166 | SUPPL | 2014-07-08 |
| 13238 | SUPPL | 2014-07-08 |
| 13237 | SUPPL | 2012-12-28 |
| 13235 | SUPPL | 2012-12-28 |
| 25558 | SUPPL | 2012-12-21 |
| 25556 | SUPPL | 2012-12-21 |
| 35154 | SUPPL | 2012-09-11 |
| 13233 | SUPPL | 2012-09-11 |
| 25553 | SUPPL | 2012-08-28 |
| 25542 | SUPPL | 2012-08-28 |
| 25557 | SUPPL | 2012-05-09 |
| 13236 | SUPPL | 2012-05-07 |
| 25551 | SUPPL | 2010-01-19 |
| 25554 | SUPPL | 2010-01-14 |
| 35164 | SUPPL | 2010-01-08 |
| 20832 | ORIG | 2010-01-07 |
| 35162 | SUPPL | 2009-11-13 |
| 35163 | SUPPL | 2009-02-04 |
| 25552 | SUPPL | 2009-02-03 |
| 35161 | SUPPL | 2008-11-20 |
| 41568 | SUPPL | 2008-08-04 |
| 41564 | SUPPL | 2008-08-04 |
| 41562 | SUPPL | 2008-08-04 |
| 20833 | SUPPL | 2008-08-04 |
| 41576 | SUPPL | 2008-07-31 |
| 41574 | SUPPL | 2008-07-31 |
| 3117 | SUPPL | 2008-05-28 |
| 41571 | SUPPL | 2008-02-19 |
| 41569 | SUPPL | 2008-02-19 |
| 25550 | SUPPL | 2008-02-14 |
| 13232 | SUPPL | 2008-02-14 |
| 3112 | SUPPL | 2008-02-05 |
| 3105 | SUPPL | 2008-01-09 |
| 13226 | SUPPL | 2007-12-27 |
| 41578 | SUPPL | 2007-11-19 |
| 41577 | SUPPL | 2007-11-19 |
| 20840 | SUPPL | 2007-11-19 |
| 35160 | SUPPL | 2007-09-26 |
| 35159 | SUPPL | 2007-09-26 |
| 25549 | SUPPL | 2007-09-25 |
| 3116 | SUPPL | 2007-09-25 |
| 41563 | SUPPL | 2007-09-24 |
| 35158 | SUPPL | 2007-08-02 |
| 35155 | SUPPL | 2007-08-02 |
| 25548 | SUPPL | 2007-08-02 |
| 41575 | SUPPL | 2007-07-06 |
| 41573 | SUPPL | 2007-07-06 |
| 41572 | SUPPL | 2007-07-06 |
| 41570 | SUPPL | 2007-07-06 |
| 41567 | SUPPL | 2007-07-06 |
| 41566 | SUPPL | 2007-07-06 |
| 41565 | SUPPL | 2007-07-06 |
| 20838 | SUPPL | 2007-07-06 |
| 20837 | SUPPL | 2007-07-06 |
| 20836 | SUPPL | 2007-07-06 |
| 20835 | SUPPL | 2007-07-06 |
| 20834 | SUPPL | 2007-07-06 |
| 20839 | SUPPL | 2007-04-11 |
| 35156 | SUPPL | 2007-02-21 |
| 3113 | SUPPL | 2007-02-12 |
| 13231 | SUPPL | 2006-10-23 |
| 3115 | SUPPL | 2006-10-23 |
| 3114 | SUPPL | 2006-09-20 |
| 35157 | SUPPL | 2006-09-15 |
| 3111 | SUPPL | 2006-03-23 |
| 3108 | SUPPL | 2006-03-01 |
| 25547 | SUPPL | 2006-01-20 |
| 3110 | SUPPL | 2006-01-20 |
| 25546 | SUPPL | 2005-12-05 |
| 13230 | SUPPL | 2005-12-05 |
| 13229 | SUPPL | 2005-11-22 |
| 13228 | SUPPL | 2005-11-22 |