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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213927-001 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2021-01-21 | 84e616aacf4f… | ||
| 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 | BluePoint Laboratories | 5efe1336-c796-4560-8110-a64c80eefb0c | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | VENLAFAXINE HYDROCHLORIDE |
| 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 | 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |