Application 214952
- Type
- NDA
- Sponsor
- CMP DEV LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIQREV | SILDENAFIL CITRATE | SUSPENSION;ORAL | EQ 10MG BASE/ML | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N214952-001 | LIQREV | SILDENAFIL CITRATE | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD | 2023-04-28 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N214952-001 | 11337979 | 2038-12-24 | U-3582 | Drug product | 2023-05-17 |
| N214952-001 | 11464778 | 2038-12-24 | U-3582 | Drug product | 2023-05-18 |
| N214952-001 | 11759468 | 2038-12-24 | U-3582 | Drug product | 2023-09-28 |
| N214952-001 | 12005062 | 2038-12-24 | U-3582 | Drug product | 2024-06-28 |
| N214952-001 | 12186321 | 2038-12-24 | U-3582 | Drug product | 2025-01-13 |
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 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD | 2023-04-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD | 2023-04-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD | 2023-04-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD | 2023-04-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD | 2023-04-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD | 2023-04-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD | 2023-04-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD | 2023-04-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD | 2023-04-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD | 2023-04-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD | 2023-04-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD, RS | 2023-04-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD, RS | 2023-04-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD, RS | 2023-04-28 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD, RS | 2023-04-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD, RS | 2023-04-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD, RS | 2023-04-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD, RS | 2023-04-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD, RS | 2023-04-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD, RS | 2023-04-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD, RS | 2023-04-28 | 3f0d92c62455… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N214952-001 | LIQREV | EQ 10MG BASE/ML | SUSPENSION / ORAL | RLD | 2023-04-28 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N214952-001 | 11337979 | 2038-12-24 | U-3582 | Drug product | 2023-05-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214952-001 | 11464778 | 2038-12-24 | U-3582 | Drug product | 2023-05-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214952-001 | 11759468 | 2038-12-24 | U-3582 | Drug product | 2023-09-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214952-001 | 12005062 | 2038-12-24 | U-3582 | Drug product | 2024-06-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214952-001 | 12186321 | 2038-12-24 | U-3582 | Drug product | 2025-01-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214952-001 | 11337979 | 2038-12-24 | U-3582 | Drug product | 2023-05-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214952-001 | 11464778 | 2038-12-24 | U-3582 | Drug product | 2023-05-18 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214952-001 | 11759468 | 2038-12-24 | U-3582 | Drug product | 2023-09-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214952-001 | 12005062 | 2038-12-24 | U-3582 | Drug product | 2024-06-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214952-001 | 12186321 | 2038-12-24 | U-3582 | Drug product | 2025-01-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N214952-001 | 11337979 | 2038-12-24 | U-3582 | Drug product | 2023-05-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N214952-001 | 11464778 | 2038-12-24 | U-3582 | Drug product | 2023-05-18 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N214952-001 | 11759468 | 2038-12-24 | U-3582 | Drug product | 2023-09-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N214952-001 | 12005062 | 2038-12-24 | U-3582 | Drug product | 2024-06-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N214952-001 | 12186321 | 2038-12-24 | U-3582 | Drug product | 2025-01-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214952-001 | 11337979 | 2038-12-24 | U-3582 | Drug product | 2023-05-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214952-001 | 11464778 | 2038-12-24 | U-3582 | Drug product | 2023-05-18 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214952-001 | 11759468 | 2038-12-24 | U-3582 | Drug product | 2023-09-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214952-001 | 12005062 | 2038-12-24 | U-3582 | Drug product | 2024-06-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214952-001 | 12186321 | 2038-12-24 | U-3582 | Drug product | 2025-01-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214952-001 | 11337979 | 2038-12-24 | U-3582 | Drug product | 2023-05-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214952-001 | 11464778 | 2038-12-24 | U-3582 | Drug product | 2023-05-18 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214952-001 | 11759468 | 2038-12-24 | U-3582 | Drug product | 2023-09-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214952-001 | 12005062 | 2038-12-24 | U-3582 | Drug product | 2024-06-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214952-001 | 12186321 | 2038-12-24 | U-3582 | Drug product | 2025-01-13 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214952-001 | 11337979 | 2038-12-24 | U-3582 | Drug product | 2023-05-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214952-001 | 11464778 | 2038-12-24 | U-3582 | Drug product | 2023-05-18 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214952-001 | 11759468 | 2038-12-24 | U-3582 | Drug product | 2023-09-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214952-001 | 12005062 | 2038-12-24 | U-3582 | Drug product | 2024-06-28 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214952-001 | 11337979 | 2038-12-24 | U-3582 | Drug product | 2023-05-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214952-001 | 11464778 | 2038-12-24 | U-3582 | Drug product | 2023-05-18 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214952-001 | 11759468 | 2038-12-24 | U-3582 | Drug product | 2023-09-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214952-001 | 12005062 | 2038-12-24 | U-3582 | Drug product | 2024-06-28 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214952-001 | 11337979 | 2038-12-24 | U-3582 | Drug product | 2023-05-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214952-001 | 11464778 | 2038-12-24 | U-3582 | Drug product | 2023-05-18 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214952-001 | 11759468 | 2038-12-24 | U-3582 | Drug product | 2023-09-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214952-001 | 12005062 | 2038-12-24 | U-3582 | Drug product | 2024-06-28 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214952-001 | 11337979 | 2038-12-24 | U-3582 | Drug product | 2023-05-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214952-001 | 11464778 | 2038-12-24 | U-3582 | Drug product | 2023-05-18 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214952-001 | 11759468 | 2038-12-24 | U-3582 | Drug product | 2023-09-28 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | PD-Rx Pharmaceuticals, Inc. | 00ee09dd-2de0-4dc4-85f6-b51ed6eabd5b | 2026-07-29 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | PD-Rx Pharmaceuticals, Inc. | f1122baa-8dee-43fc-bd3d-501a55b696b3 | 2026-07-29 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| Sildenafil | SILDENAFIL CITRATE | Yaral Pharma Inc. | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2026-07-17 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| Vybrique | SILDENAFIL CITRATE | IBSA Pharma Inc. | 9213fec1-e0c0-4ef7-9718-d97922a3f4d8 | 2026-07-08 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| Sildenafil | SILDENAFIL CITRATE | Eugia US LLC | bb92d686-a81e-4b91-8048-693af0534cb3 | 2026-07-01 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | Umedica Laboratories USA Inc. | 90477a51-63ba-43f4-a74b-4659a946093c | 2026-05-13 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | NIVAGEN PHARMACEUTICALS, INC. | 5ac95dd0-57e4-495c-bf8d-b2e5bbe33e20 | 2026-04-27 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | Northstar Rx LLC | 8127ff38-2761-49ec-8ce7-7f971f521cfb | 2026-02-26 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| Sildenafil Citrate | SILDENAFIL CITRATE | Zydus Lifesciences Limited | 2ef4d02f-76ee-4f67-9f4f-1cd554decb31 | 2026-02-02 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| sildenafil CITRATE | SILDENAFIL CITRATE | Aurobindo Pharma Limited | b60b4fdc-9b78-45e6-8438-8a30f83ed976 | 2026-02-02 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| Sildenafil Citrate | SILDENAFIL CITRATE | Zydus Pharmaceuticals (USA) Inc. | b2f04ce4-f19c-403d-8a83-74f123e5d30a | 2026-02-02 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | Proficient Rx LP | 8780c159-8b61-402b-afbe-64f5c85d3886 | 2025-11-01 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | Proficient Rx LP | 30ce6e7f-716e-4a68-a4fb-2bb2d34ed052 | 2025-11-01 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | Proficient Rx LP | 1add0cab-8873-4cd1-ab53-e05c4ac458b1 | 2025-10-01 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | PD-Rx Pharmaceuticals, Inc. | dc4430cc-8238-4d6d-99ff-bbb9d0b51bd1 | 2025-04-04 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | Advanced Rx of Tennessee, LLC | 30cb7d6a-ce40-c794-e063-6294a90a6861 | 2025-03-20 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | Preferred Pharmaceuticals Inc. | 5846bff2-6a93-46a7-a547-04459c590814 | 2025-01-20 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| Revatio | SILDENAFIL CITRATE | Viatris Specialty LLC | 3bb9363e-b28d-4019-8aae-539233dca214 | 2024-12-18 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | A-S Medication Solutions | 28a3376b-e50e-4789-9916-803ba29a1522 | 2024-10-25 | Warnings, Adverse reactions | SILDENAFIL CITRATE |
| Sildenafil Citrate | SILDENAFIL CITRATE | NuCare Pharmaceuticals, Inc. | 20ead8ca-7cec-2d80-e063-6394a90af548 | 2024-08-30 | Warnings, Adverse reactions | SILDENAFIL CITRATE |