Application 209379
- Type
- NDA
- Sponsor
- AM REGENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SELENIOUS ACID | SELENIOUS ACID | SOLUTION;INTRAVENOUS | EQ 600MCG BASE/10ML (EQ 60MCG BASE/ML) | Yes | Yes |
| 002 | SELENIOUS ACID | SELENIOUS ACID | SOLUTION;INTRAVENOUS | EQ 60MCG BASE/ML (EQ 60MCG BASE/ML) | Yes | Yes |
| 003 | SELENIOUS ACID | SELENIOUS ACID | SOLUTION;INTRAVENOUS | EQ 12MCG BASE/2ML (EQ 6MCG BASE/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N209379-001 | SELENIOUS ACID | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-04-30 |
| N209379-002 | SELENIOUS ACID | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-01-25 |
| N209379-003 | SELENIOUS ACID | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-08-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N209379-001 | AP |
| N209379-002 | AP |
| N209379-003 | AP |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N209379-001 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | |
| N209379-001 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | |
| N209379-002 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | |
| N209379-002 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | |
| N209379-003 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | |
| N209379-003 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-04-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N209379-002 | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-01-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N209379-003 | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-08-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-04-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209379-002 | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-01-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209379-003 | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-08-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-04-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209379-002 | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-01-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209379-003 | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-08-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-04-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N209379-002 | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-01-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209379-003 | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-08-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-04-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209379-002 | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-01-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209379-003 | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-08-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-04-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209379-002 | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-01-25 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209379-003 | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-08-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-04-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209379-002 | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-01-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209379-003 | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-08-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-04-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209379-002 | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-01-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209379-003 | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-08-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-04-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209379-002 | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-01-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209379-003 | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-08-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-04-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209379-002 | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-01-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209379-003 | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-08-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-04-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209379-002 | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-01-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209379-003 | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-08-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-04-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209379-002 | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-01-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209379-003 | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-08-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-04-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209379-002 | SELENIOUS ACID | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-01-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209379-003 | SELENIOUS ACID | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-08-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209379-001 | SELENIOUS ACID | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-04-30 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N209379-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N209379-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N209379-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N209379-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209379-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209379-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209379-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209379-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N209379-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N209379-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209379-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209379-002 | AP | 1 | b8a1b40f171c… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N209379-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N209379-002 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N209379-003 | AP | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N209379-001 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209379-001 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209379-002 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209379-002 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209379-003 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209379-003 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209379-001 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209379-001 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209379-002 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209379-002 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209379-003 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209379-003 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209379-001 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209379-001 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209379-002 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209379-002 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209379-003 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209379-003 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209379-001 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209379-001 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209379-002 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209379-002 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209379-003 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209379-003 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209379-001 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209379-001 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209379-002 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209379-002 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209379-003 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209379-003 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209379-001 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209379-001 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209379-002 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209379-002 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209379-003 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209379-003 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209379-001 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209379-001 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209379-002 | 11998565 | 2041-07-01 | Drug product | 2024-06-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209379-002 | 12150957 | 2041-07-01 | U-4039 | 2024-12-03 | 03ed91905a0d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209379-001 | NCE | 2024-04-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209379-002 | NCE | 2024-04-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209379-003 | NCE | 2024-04-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209379-001 | NCE | 2024-04-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209379-002 | NCE | 2024-04-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209379-003 | NCE | 2024-04-30 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209379-001 | NCE | 2024-04-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209379-002 | NCE | 2024-04-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209379-003 | NCE | 2024-04-30 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209379-001 | NCE | 2024-04-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209379-002 | NCE | 2024-04-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209379-003 | NCE | 2024-04-30 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N209379-001 | NCE | 2024-04-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N209379-002 | NCE | 2024-04-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N209379-003 | NCE | 2024-04-30 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209379-001 | NCE | 2024-04-30 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209379-002 | NCE | 2024-04-30 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209379-003 | NCE | 2024-04-30 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209379-001 | NCE | 2024-04-30 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209379-002 | NCE | 2024-04-30 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209379-003 | NCE | 2024-04-30 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209379-001 | NCE | 2024-04-30 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209379-002 | NCE | 2024-04-30 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209379-003 | NCE | 2024-04-30 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N209379-001 | NCE | 2024-04-30 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N209379-002 | NCE | 2024-04-30 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N209379-003 | NCE | 2024-04-30 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209379-001 | NCE | 2024-04-30 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209379-002 | NCE | 2024-04-30 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209379-003 | NCE | 2024-04-30 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N209379-001 | NCE | 2024-04-30 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N209379-002 | NCE | 2024-04-30 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N209379-003 | NCE | 2024-04-30 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N209379-001 | NCE | 2024-04-30 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N209379-002 | NCE | 2024-04-30 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N209379-003 | NCE | 2024-04-30 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N209379-001 | NCE | 2024-04-30 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N209379-001 | NCE | 2024-04-30 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N209379-002 | NCE | 2024-04-30 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N209379-003 | NCE | 2024-04-30 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| Selenious Acid | SELENIOUS ACID | American Regent, Inc. | 49324999-50e3-43ed-a8dd-156d6dbedd9f | 2021-08-01 | Warnings, Adverse reactions | 209379 NDA209379 0517-6560 0517-6502 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0517-6502 | Selenious Acid | Selenious Acid | American Regent, Inc. | NDA | Current |
| 0517-6560 | Selenious Acid | Selenious Acid | American Regent, Inc. | NDA | Current |
| 0517-6560 | Selenious Acid | Selenious Acid | American Regent, Inc. | NDA | Current |
| 0517-6560 | Selenious Acid | Selenious Acid | American Regent, Inc. | NDA | Current |
| 0517-6560 | Selenious Acid | Selenious Acid | American Regent, Inc. | NDA | Current |
| 0517-6560 | Selenious Acid | Selenious Acid | American Regent, Inc. | NDA | Current |
| 0517-6560 | Selenious Acid | Selenious Acid | American Regent, Inc. | NDA | Current |
| 0517-6560 | Selenious Acid | Selenious Acid | American Regent, Inc. | NDA | Current |
| 0517-6560 | Selenious Acid | Selenious Acid | American Regent, Inc. | NDA | Current |