Application 214520
- Type
- NDA
- Sponsor
- CORMEDIX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEFENCATH | HEPARIN SODIUM; TAUROLIDINE | SOLUTION;N/A | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | Yes | Yes |
| 002 | DEFENCATH | HEPARIN SODIUM; TAUROLIDINE | SOLUTION;N/A | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N214520-001 | DEFENCATH | HEPARIN SODIUM; TAUROLIDINE | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | |
| N214520-002 | DEFENCATH | HEPARIN SODIUM; TAUROLIDINE | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N214520-001 | 7696182 | 2026-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 |
| N214520-001 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | |
| N214520-002 | 7696182 | 2026-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 |
| N214520-002 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N214520-001 | NCE | 2028-11-15 |
| N214520-001 | GAIN | 2033-11-15 |
| N214520-002 | NCE | 2028-11-15 |
| N214520-002 | GAIN | 2033-11-15 |
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 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / INJECTION | RLD, RS | 2023-11-15 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / INJECTION | RLD, RS | 2023-11-15 | ea1830bbd6c7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N214520-001 | DEFENCATH | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N214520-002 | DEFENCATH | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION / N/A | RLD, RS | 2023-11-15 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N214520-001 | 7696182 | 2026-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N214520-001 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N214520-002 | 7696182 | 2026-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N214520-002 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N214520-001 | 7696182 | 2026-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N214520-001 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N214520-002 | 7696182 | 2026-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N214520-002 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214520-001 | 7696182 | 2026-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214520-001 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214520-002 | 7696182 | 2026-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214520-002 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214520-001 | 7696182 | 2026-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214520-001 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214520-002 | 7696182 | 2026-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214520-002 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214520-001 | 7696182 | 2026-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N214520-001 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214520-002 | 7696182 | 2026-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N214520-002 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214520-001 | 7696182 | 2025-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214520-001 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214520-002 | 7696182 | 2025-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214520-002 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214520-001 | 7696182 | 2025-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214520-001 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214520-002 | 7696182 | 2025-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214520-002 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214520-001 | 8541393 | 2024-11-02 | U-3774 | Drug substance, Drug product | 2023-12-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214520-001 | 9339036 | 2024-11-02 | Drug substance, Drug product | 2023-12-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214520-001 | 7696182 | 2025-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214520-001 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214520-002 | 8541393 | 2024-11-02 | U-3774 | Drug substance, Drug product | 2023-12-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214520-002 | 9339036 | 2024-11-02 | Drug substance, Drug product | 2023-12-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214520-002 | 7696182 | 2025-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214520-002 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214520-001 | 8541393 | 2024-11-02 | U-3774 | Drug substance, Drug product | 2023-12-14 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214520-001 | 9339036 | 2024-11-02 | Drug substance, Drug product | 2023-12-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214520-001 | 7696182 | 2025-05-16 | U-3774 | Drug substance, Drug product | 2023-12-14 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214520-001 | 11738120 | 2042-04-15 | Drug substance, Drug product | 2023-12-14 | 2680178bc6a6… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214520-001 | NCE | 2028-11-15 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214520-001 | GAIN | 2033-11-15 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214520-002 | NCE | 2028-11-15 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214520-002 | GAIN | 2033-11-15 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N214520-001 | NCE | 2028-11-15 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N214520-001 | GAIN | 2033-11-15 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N214520-002 | NCE | 2028-11-15 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N214520-002 | GAIN | 2033-11-15 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214520-001 | NCE | 2028-11-15 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214520-001 | GAIN | 2033-11-15 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214520-002 | NCE | 2028-11-15 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214520-002 | GAIN | 2033-11-15 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214520-001 | NCE | 2028-11-15 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214520-001 | GAIN | 2033-11-15 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214520-002 | NCE | 2028-11-15 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214520-002 | GAIN | 2033-11-15 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214520-001 | NCE | 2028-11-15 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214520-001 | GAIN | 2033-11-15 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214520-002 | NCE | 2028-11-15 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214520-002 | GAIN | 2033-11-15 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N214520-001 | NCE | 2028-11-15 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N214520-001 | GAIN | 2033-11-15 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N214520-002 | NCE | 2028-11-15 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N214520-002 | GAIN | 2033-11-15 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N214520-001 | NCE | 2028-11-15 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N214520-001 | GAIN | 2033-11-15 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N214520-002 | NCE | 2028-11-15 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N214520-002 | GAIN | 2033-11-15 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N214520-001 | NCE | 2028-11-15 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N214520-001 | GAIN | 2033-11-15 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N214520-002 | NCE | 2028-11-15 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N214520-002 | GAIN | 2033-11-15 | 1c564ffb4f44… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N214520-001 | NCE | 2028-11-15 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N214520-001 | GAIN | 2033-11-15 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N214520-002 | NCE | 2028-11-15 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N214520-002 | GAIN | 2033-11-15 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| DEFENCATH | TAUROLIDINE AND HEPARIN | CorMedix Inc. | 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6 | 2026-09-04 | Warnings, Adverse reactions | 214520 NDA214520 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.