Application 021400
- Type
- NDA
- Sponsor
- BAYER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVITRA | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 5MG | Yes | No |
| 002 | LEVITRA | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 10MG | Yes | No |
| 003 | LEVITRA | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | LEVITRA | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 20MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021400-001 | LEVITRA | VARDENAFIL HYDROCHLORIDE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | |
| N021400-002 | LEVITRA | VARDENAFIL HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | |
| N021400-003 | LEVITRA | VARDENAFIL HYDROCHLORIDE | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | |
| N021400-004 | LEVITRA | VARDENAFIL HYDROCHLORIDE | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021400-001 | 8273876 | 2027-07-23 | U-1288 | 2012-10-24 | |
| N021400-002 | 8273876 | 2027-07-23 | U-1288 | ||
| N021400-003 | 8273876 | 2027-07-23 | U-1288 | ||
| N021400-004 | 8273876 | 2027-07-23 | U-1288 |
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 | N021400-001 | LEVITRA | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021400-002 | LEVITRA | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021400-003 | LEVITRA | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021400-004 | LEVITRA | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021400-001 | LEVITRA | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021400-002 | LEVITRA | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021400-003 | LEVITRA | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021400-004 | LEVITRA | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021400-001 | LEVITRA | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021400-002 | LEVITRA | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021400-003 | LEVITRA | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021400-004 | LEVITRA | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021400-001 | LEVITRA | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021400-002 | LEVITRA | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021400-003 | LEVITRA | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021400-004 | LEVITRA | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021400-001 | LEVITRA | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021400-002 | LEVITRA | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021400-003 | LEVITRA | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021400-004 | LEVITRA | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021400-001 | LEVITRA | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021400-002 | LEVITRA | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021400-003 | LEVITRA | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021400-004 | LEVITRA | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021400-001 | LEVITRA | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021400-002 | LEVITRA | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021400-003 | LEVITRA | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021400-004 | LEVITRA | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021400-001 | LEVITRA | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021400-002 | LEVITRA | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021400-003 | LEVITRA | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021400-004 | LEVITRA | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021400-001 | LEVITRA | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021400-002 | LEVITRA | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021400-003 | LEVITRA | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021400-004 | LEVITRA | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021400-001 | LEVITRA | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021400-002 | LEVITRA | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021400-003 | LEVITRA | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021400-004 | LEVITRA | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2003-08-19 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021400-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021400-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021400-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021400-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021400-004 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021400-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021400-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021400-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021400-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021400-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021400-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021400-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021400-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021400-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021400-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021400-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021400-004 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021400-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021400-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021400-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021400-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021400-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021400-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021400-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021400-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021400-004 | AB | 1 | ea99ee380514… |
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 | N021400-001 | 8273876 | 2027-07-23 | U-1288 | 2012-10-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021400-002 | 8273876 | 2027-07-23 | U-1288 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021400-003 | 8273876 | 2027-07-23 | U-1288 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021400-004 | 8273876 | 2027-07-23 | U-1288 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021400-001 | 8273876 | 2027-07-23 | U-1288 | 2012-10-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021400-002 | 8273876 | 2027-07-23 | U-1288 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021400-003 | 8273876 | 2027-07-23 | U-1288 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021400-004 | 8273876 | 2027-07-23 | U-1288 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021400-001 | 8273876 | 2027-07-23 | U-1288 | 2012-10-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021400-002 | 8273876 | 2027-07-23 | U-1288 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021400-003 | 8273876 | 2027-07-23 | U-1288 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021400-004 | 8273876 | 2027-07-23 | U-1288 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021400-001 | 8273876 | 2027-07-23 | U-1288 | 2012-10-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021400-002 | 8273876 | 2027-07-23 | U-1288 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021400-003 | 8273876 | 2027-07-23 | U-1288 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021400-004 | 8273876 | 2027-07-23 | U-1288 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021400-001 | 8273876 | 2027-07-23 | U-1288 | 2012-10-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021400-002 | 8273876 | 2027-07-23 | U-1288 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021400-003 | 8273876 | 2027-07-23 | U-1288 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021400-004 | 8273876 | 2027-07-23 | U-1288 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021400-001 | 8273876 | 2027-07-23 | U-1288 | 2012-10-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021400-002 | 8273876 | 2027-07-23 | U-1288 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021400-003 | 8273876 | 2027-07-23 | U-1288 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021400-004 | 8273876 | 2027-07-23 | U-1288 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021400-001 | 8273876 | 2027-07-23 | U-1288 | 2012-10-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021400-002 | 8273876 | 2027-07-23 | U-1288 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021400-003 | 8273876 | 2027-07-23 | U-1288 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021400-004 | 8273876 | 2027-07-23 | U-1288 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021400-001 | 8273876 | 2027-07-23 | U-1288 | 2012-10-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021400-002 | 8273876 | 2027-07-23 | U-1288 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021400-003 | 8273876 | 2027-07-23 | U-1288 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021400-004 | 8273876 | 2027-07-23 | U-1288 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021400-001 | 8273876 | 2027-07-23 | U-1288 | 2012-10-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021400-002 | 8273876 | 2027-07-23 | U-1288 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021400-003 | 8273876 | 2027-07-23 | U-1288 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021400-004 | 8273876 | 2027-07-23 | U-1288 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021400-001 | 8273876 | 2027-07-23 | U-1288 | 2012-10-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021400-002 | 8273876 | 2027-07-23 | U-1288 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021400-003 | 8273876 | 2027-07-23 | U-1288 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021400-004 | 8273876 | 2027-07-23 | U-1288 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Lannett Company, Inc. | 2782efed-6198-47b9-81ac-3e255e2ab7f6 | 2026-07-15 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | AvKARE | 80c4793d-e19e-10f0-e053-2991aa0a4620 | 2026-01-15 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Chartwell RX, LLC | 57a0c163-a5e8-4c6e-a4ea-114cb2668407 | 2025-12-10 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Bryant Ranch Prepack | 083a3282-254f-4042-b0eb-70f76a279f10 | 2025-11-06 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Bryant Ranch Prepack | 6d2859a7-6def-455f-856b-9db86b1fd355 | 2025-11-06 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Bryant Ranch Prepack | 666a622b-2464-4c55-8c90-0f1cc85bc1e9 | 2025-10-28 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Bryant Ranch Prepack | 8791997d-3b86-45af-988f-808e259da506 | 2025-10-28 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | AvKARE | 3b03952b-d404-09cd-e063-6294a90a8b2c | 2025-07-28 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Bryant Ranch Prepack | d8a5cc4b-9d9d-43af-9ee4-57381aa6368a | 2024-05-28 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Bryant Ranch Prepack | 31be68b0-ac7e-42d0-9435-1f0a329b63d8 | 2024-04-03 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | e593ab58-70a4-4095-8091-16a4b6d49e4d | 2023-12-08 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Macleods Pharmaceuticals Limited | a38de6e1-21ca-4ebe-a3c7-6f849cf8b675 | 2023-04-10 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | d2dce236-257e-44b6-93a9-9f0280257c6a | 2023-03-22 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Limited | 9b8da728-8f52-4c1f-9f0c-4bd9736e912f | 2023-01-24 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 09366eb3-93e0-41d9-bf9a-24335ed3555f | 2021-01-27 | Warnings, Adverse reactions | VARDENAFIL HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0173-0829 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0829 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0829 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0829 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0830 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0830 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0830 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0830 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0830 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0831 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0831 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0831 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0831 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0831 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0831 | Levitra | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 43353-323 | Levitra | vardenafil hydrochloride | APHENA PHARMA SOLUTIONS - TENNESSEE, INC. | NDA | Current |
| 43353-741 | Levitra | vardenafil hydrochloride | APHENA PHARMA SOLUTIONS - TENNESSEE, INC. | NDA | Current |
| 43353-744 | Levitra | vardenafil hydrochloride | APHENA PHARMA SOLUTIONS - TENNESSEE, INC. | NDA | Current |
| 43353-748 | Levitra | vardenafil hydrochloride | APHENA PHARMA SOLUTIONS - TENNESSEE, INC. | NDA | Current |
| 55289-193 | Levitra | vardenafil hydrochloride | PD-Rx Pharmaceuticals, In | NDA | Current |
| 55289-193 | Levitra | vardenafil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-193 | Levitra | vardenafil hydrochloride | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 63629-3372 | Levitra | vardenafil hydrochloride | Bryant Ranch Prepack | NDA | Current |
| 67544-507 | Levitra | vardenafil hydrochloride | APHENA PHARMA SOLUTIONS - TENNESSEE, INC. | NDA | Current |
| 67544-512 | Levitra | vardenafil hydrochloride | APHENA PHARMA SOLUTIONS - TENNESSEE, INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73777 | SUPPL | 2023-03-16 |
| 49570 | SUPPL | 2017-08-29 |
| 49447 | SUPPL | 2017-08-17 |
| 15370 | SUPPL | 2015-09-23 |
| 27673 | SUPPL | 2015-09-17 |
| 15369 | SUPPL | 2014-05-02 |
| 27672 | SUPPL | 2014-04-30 |
| 15368 | SUPPL | 2013-08-06 |
| 27671 | SUPPL | 2013-08-05 |
| 15367 | SUPPL | 2011-11-30 |
| 27670 | SUPPL | 2011-11-28 |
| 5257 | SUPPL | 2008-05-21 |
| 5256 | SUPPL | 2008-03-21 |
| 15366 | SUPPL | 2008-03-20 |
| 5255 | SUPPL | 2007-10-22 |
| 44121 | ORIG | 2007-10-18 |
| 36821 | SUPPL | 2007-10-18 |
| 5254 | SUPPL | 2007-04-20 |
| 15365 | SUPPL | 2007-04-09 |
| 5253 | SUPPL | 2005-07-15 |
| 36820 | SUPPL | 2005-07-08 |
| 27669 | SUPPL | 2005-05-17 |
| 15364 | SUPPL | 2005-05-17 |
| 21637 | ORIG | 2003-10-29 |
| 36819 | ORIG | 2003-08-28 |
| 5252 | ORIG | 2003-08-28 |