Application 212277
- Type
- ANDA
- Sponsor
- ANNORA PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 37.5MG BASE | No | No |
| 002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 75MG BASE | No | No |
| 003 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | CAPSULE, 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 |
|---|---|---|---|---|---|---|---|
| A212277-001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | |
| A212277-002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | |
| A212277-003 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212277-001 | AB |
| A212277-002 | AB |
| A212277-003 | 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 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212277-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212277-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212277-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212277-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212277-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212277-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212277-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212277-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212277-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212277-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212277-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212277-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212277-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212277-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212277-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212277-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212277-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212277-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212277-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212277-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212277-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212277-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212277-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212277-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212277-002 | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212277-003 | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212277-001 | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2019-07-08 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A212277-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212277-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212277-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212277-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212277-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212277-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212277-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212277-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212277-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212277-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212277-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212277-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212277-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212277-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212277-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212277-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212277-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212277-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212277-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212277-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212277-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212277-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212277-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212277-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212277-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212277-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212277-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212277-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212277-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212277-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212277-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212277-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212277-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212277-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212277-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212277-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212277-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212277-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212277-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212277-001 | 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 |
|---|---|---|---|---|---|---|
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | c0fa9a3b-692e-2c2e-e053-2995a90aa83a | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 68071-2393 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | REMEDYREPACK INC. | c41d847b-88ba-49a5-9d73-269ac4caa4ed | 2026-01-16 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | b18d726e-cdb2-4c80-a49d-330cddee17e9 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 68788-8072 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 6c1d0d4f-c8e2-4035-8f4e-7a46bfe3f059 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 68788-7891 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 653f3f95-98d0-4ce0-bf10-ac7938be690e | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 68788-8068 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | AvPAK | 2efde38c-250e-d1b9-e063-6394a90a1b74 | 2025-02-25 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 2c2bb0e6-5a73-ff57-e063-6294a90a88d3 | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 |
| Venlafaxine HCL ER | VENLAFAXINE HCL | Advanced Rx Pharmacy of Tennessee, LLC | d8e00b3d-29de-1de5-e053-2995a90acb51 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 80425-0194 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 20a7d922-7f7c-4de4-b5fd-55c13aab060c | 2024-10-31 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 71335-1868 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | baae24d6-e425-4cfc-9a53-3cd223b6d344 | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 71335-9605 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Bryant Ranch Prepack | 1e1119f7-0c2e-4587-a24d-0066f73b2e65 | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 71335-1812 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 0ee91447-2c23-4519-81cc-550b5416dd6b | 2024-08-05 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 31722-003 31722-002 31722-004 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | df7e0982-3eb0-4bdf-8f7f-4f4a48476ed7 | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 50090-5890 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | A-S Medication Solutions | 52319578-f7cc-4b87-b532-f341854e40b4 | 2023-07-22 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 50090-5942 |
| Venlafaxine Hydrochloride | VENLAFAXINE HYDROCHLORIDE | Proficient Rx LP | 922388b3-fc1c-46c6-b314-9049bd042df7 | 2023-06-01 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Annora Pharma Private Limited | e901e476-58bd-4204-baaa-a4634ae65ab3 | 2020-11-18 | Boxed warning, Warnings, Adverse reactions | 212277 ANDA212277 71785-1008 71785-1007 71785-1006 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-002 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-002 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-003 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-003 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-004 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-004 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 50090-5890 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5891 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5892 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5942 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5942 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 55700-914 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-914 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-914 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-975 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 68071-2393 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2393 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2427 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2427 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2588 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2703 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7891 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7891 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8068 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-8068 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-8072 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-8072 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 71335-1812 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1812 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1868 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1868 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-9605 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71785-1006 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Annora Pharma Private Limited | ANDA | Current |
| 71785-1007 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Annora Pharma Private Limited | ANDA | Current |
| 71785-1008 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | Annora Pharma Private Limited | ANDA | Current |
| 80425-0194 | Venlafaxine HCL | Venlafaxine HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |