Application 020696
- Type
- NDA
- Sponsor
- PAR PHARM INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ANTIZOL | FOMEPIZOLE | INJECTABLE;INJECTION | 1.5GM/1.5ML (1GM/ML) | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020696-001 | ANTIZOL | FOMEPIZOLE | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product |
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 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) | INJECTABLE / INJECTION | RLD | 1997-12-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) | INJECTABLE / INJECTION | RLD | 1997-12-04 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) | INJECTABLE / INJECTION | RLD | 1997-12-04 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) | INJECTABLE / INJECTION | RLD | 1997-12-04 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) | INJECTABLE / INJECTION | RLD | 1997-12-04 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) | INJECTABLE / INJECTION | RLD | 1997-12-04 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) | INJECTABLE / INJECTION | RLD | 1997-12-04 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) | INJECTABLE / INJECTION | RLD | 1997-12-04 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) | INJECTABLE / INJECTION | RLD | 1997-12-04 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) | INJECTABLE / INJECTION | RLD | 1997-12-04 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) | INJECTABLE / INJECTION | RLD | 1997-12-04 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020696-001 | ANTIZOL | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1997-12-04 | cb3db0bc1861… |
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 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020696-001 | 7553863 | 2027-06-30 | Drug substance, Drug product | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Fomepizole | FOMEPIZOLE | Zydus Pharmaceuticals USA Inc. | 256910fe-91f2-48f6-b0b4-55edc52dacd4 | 2025-11-20 | Adverse reactions | FOMEPIZOLE |
| Fomepizole | FOMEPIZOLE | Navinta LLC | 6fed6052-f159-46d6-8be1-31e18a7ba918 | 2024-12-19 | Adverse reactions | FOMEPIZOLE |
| Fomepizole | FOMEPIZOLE | Sagent Pharmaceuticals | 1dea37fd-ec17-416e-b28e-980a87d49e1a | 2023-10-26 | Adverse reactions | FOMEPIZOLE |
| Fomepizole | FOMEPIZOLE | Gland Pharma Limited | 7e133194-dacb-446a-a657-2d2430a02373 | 2023-07-07 | Adverse reactions | FOMEPIZOLE |
| Fomepizole | FOMEPIZOLE | Mylan Institutional LLC | 911312e2-3a7c-4c97-88a8-b8d92cd12923 | 2021-04-15 | Adverse reactions | FOMEPIZOLE |
| fomepizole | FOMEPIZOLE | American Regent, Inc. | a31d0148-2729-49de-b666-f24b0dfd2401 | 2020-02-11 | Adverse reactions | FOMEPIZOLE |
| fomepizole | FOMEPIZOLE | American Regent, Inc. | 82dc2920-af7f-4e43-9f6d-8877a71884cd | 2019-12-06 | Adverse reactions | FOMEPIZOLE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 46129-200 | Antizol | fomepizole | PALADIN LABORATORIES (USA) INC | NDA | Current |