Application 213927
- Type
- ANDA
- Sponsor
- DEXCEL PHARMA
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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213927-001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2021-01-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2021-01-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 5aa47cf7b7d7… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-21 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2021-01-21 | 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 | A213927-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213927-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213927-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213927-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213927-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213927-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213927-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213927-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213927-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213927-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213927-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213927-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213927-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213927-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213927-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A213927-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A213927-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A213927-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A213927-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213927-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A213927-001 | AB | 1 | 5aa47cf7b7d7… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213927-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A213927-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A213927-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213927-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213927-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213927-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213927-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A213927-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A213927-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213927-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A213927-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A213927-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213927-001 | 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 | Advagen Pharma Ltd. | 48a75840-64e4-4d44-9a62-009373003105 | 2026-08-25 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 3eef522f-9e95-4668-bb12-09fd47ed0daf | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | b1d21366-f686-4e20-a10f-0c25f517db38 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | f56a0f70-bbb1-4e69-b969-965a72f0e2f0 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 4e3053b9-cdec-4f4d-85ae-2e55cf1cc185 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 50d3b487-9f65-4e2f-b6eb-9533964f8972 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | ac9b972d-8b8a-4727-90c2-b208f91272fd | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Yaopharma Co., Ltd. | 38fd2c97-cd30-2f7d-e054-00144ff8d46c | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 4a82cef5-693e-46e9-90c4-bff753cdce37 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | f50029b8-7d05-445a-9d9f-71a1aee6088b | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | 5a990dbd-f280-4caf-b950-4703ee98b230 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | d94e5404-f728-4e4b-af99-8a8e4dfae227 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | c37a73fa-ceee-4555-a61b-e1e66ad6e97d | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | 7fcd7995-81fb-4368-bd4c-3726b2ae363e | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| venlafaxine | VENLAFAXINE HYDROCHLORIDE | Coupler LLC | 53e5c5a2-b8e7-3d75-e063-6294a90a508b | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Coupler LLC | 5358f20f-b864-0aae-e063-6394a90a7eab | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Coupler LLC | 5359012e-a868-3aa3-e063-6294a90a74e2 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | NorthStar RxLLC | b865c175-e75d-4cb4-ac29-dec72226302c | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine hydrochloride | VENLAFAXINE HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 3e51f786-3691-4ec4-836b-7f2c9a385aa7 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | Venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Asclemed USA, Inc. | c69d16fd-b82d-4708-aece-ab4f60b29cc6 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-2606 | Venlafaxine | Venlafaxine | Lannett Company, Inc. | ANDA | Current |
| 0527-2606 | Venlafaxine | Venlafaxine | Lannett Company, Inc. | ANDA | Current |
| 0527-2606 | Venlafaxine | Venlafaxine | Lannett Company, Inc. | ANDA | Current |
| 0527-2616 | Venlafaxine | Venlafaxine | Lannett Company, Inc. | ANDA | Current |
| 70518-3269 | Venlafaxine | Venlafaxine | REMEDYREPACK INC. | ANDA | Current |