Application 022205
- Type
- NDA
- Sponsor
- VALEANT PHARMS INTL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GIAZO | BALSALAZIDE DISODIUM | TABLET;ORAL | 1.1GM | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022205-001 | GIAZO | BALSALAZIDE DISODIUM | 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-02-03 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022205-001 | 9192616 | 2026-08-02 | U-1229 | 2016-01-19 | |
| N022205-001 | 7452872 | 2026-08-24 | U-1229 | 2012-03-02 | |
| N022205-001 | 7625884 | 2026-08-24 | U-1229 | 2012-03-02 | |
| N022205-001 | 8497256 | 2031-06-23 | U-1229 | 2013-08-23 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N022205-001 | GIAZO | 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-02-03 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N022205-001 | GIAZO | 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-02-03 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022205-001 | GIAZO | 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-02-03 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022205-001 | GIAZO | 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-02-03 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N022205-001 | 9192616 | 2026-08-02 | U-1229 | 2016-01-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N022205-001 | 7452872 | 2026-08-24 | U-1229 | 2012-03-02 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N022205-001 | 7625884 | 2026-08-24 | U-1229 | 2012-03-02 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N022205-001 | 8497256 | 2031-06-23 | U-1229 | 2013-08-23 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N022205-001 | 9192616 | 2026-08-02 | U-1229 | 2016-01-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022205-001 | 7452872 | 2026-08-24 | U-1229 | 2012-03-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022205-001 | 7625884 | 2026-08-24 | U-1229 | 2012-03-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022205-001 | 8497256 | 2031-06-23 | U-1229 | 2013-08-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022205-001 | 9192616 | 2026-08-02 | U-1229 | 2016-01-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022205-001 | 7452872 | 2026-08-24 | U-1229 | 2012-03-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022205-001 | 7625884 | 2026-08-24 | U-1229 | 2012-03-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022205-001 | 8497256 | 2031-06-23 | U-1229 | 2013-08-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022205-001 | 9192616 | 2026-08-02 | U-1229 | 2016-01-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022205-001 | 7452872 | 2026-08-24 | U-1229 | 2012-03-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022205-001 | 7625884 | 2026-08-24 | U-1229 | 2012-03-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022205-001 | 8497256 | 2031-06-23 | U-1229 | 2013-08-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022205-001 | 9192616 | 2026-08-02 | U-1229 | 2016-01-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022205-001 | 7452872 | 2026-08-24 | U-1229 | 2012-03-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022205-001 | 7625884 | 2026-08-24 | U-1229 | 2012-03-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022205-001 | 8497256 | 2031-06-23 | U-1229 | 2013-08-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022205-001 | 9192616 | 2026-08-02 | U-1229 | 2016-01-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022205-001 | 7452872 | 2026-08-24 | U-1229 | 2012-03-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022205-001 | 7625884 | 2026-08-24 | U-1229 | 2012-03-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022205-001 | 8497256 | 2031-06-23 | U-1229 | 2013-08-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022205-001 | 9192616 | 2026-08-02 | U-1229 | 2016-01-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022205-001 | 7452872 | 2026-08-24 | U-1229 | 2012-03-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022205-001 | 7625884 | 2026-08-24 | U-1229 | 2012-03-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022205-001 | 8497256 | 2031-06-23 | U-1229 | 2013-08-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022205-001 | 9192616 | 2026-08-02 | U-1229 | 2016-01-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022205-001 | 7452872 | 2026-08-24 | U-1229 | 2012-03-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022205-001 | 7625884 | 2026-08-24 | U-1229 | 2012-03-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022205-001 | 8497256 | 2031-06-23 | U-1229 | 2013-08-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022205-001 | 9192616 | 2026-08-02 | U-1229 | 2016-01-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022205-001 | 7452872 | 2026-08-24 | U-1229 | 2012-03-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022205-001 | 7625884 | 2026-08-24 | U-1229 | 2012-03-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022205-001 | 8497256 | 2031-06-23 | U-1229 | 2013-08-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022205-001 | 9192616 | 2026-08-02 | U-1229 | 2016-01-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022205-001 | 7452872 | 2026-08-24 | U-1229 | 2012-03-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022205-001 | 7625884 | 2026-08-24 | U-1229 | 2012-03-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022205-001 | 8497256 | 2031-06-23 | U-1229 | 2013-08-23 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| Balsalazide Disodium | BALSALAZIDE DISODIUM | Apotex Corp. | f12ffa32-d14b-e9d9-e957-2ef08b64e8b4 | 2026-09-09 | Warnings, Adverse reactions | BALSALAZIDE DISODIUM |
| Balsalazide Disodium | BALSALAZIDE DISODIUM | AvPAK | 509b83b6-cde6-393b-8560-557793b6a529 | 2025-12-30 | Warnings, Adverse reactions | BALSALAZIDE DISODIUM |
| Balsalazide Disodium | BALSALAZIDE DISODIUM | PD-Rx Pharmaceuticals, Inc. | b3ecc533-dd55-4a2f-84c4-ecd454aae766 | 2025-10-08 | Warnings, Adverse reactions | BALSALAZIDE DISODIUM |
| balsalazide disodium | BALSALAZIDE DISODIUM | Zydus Lifesciences Limited | c573888c-4aa3-4fdb-bf3f-1cf3d78d922b | 2025-06-13 | Warnings, Adverse reactions | BALSALAZIDE DISODIUM |
| balsalazide disodium | BALSALAZIDE DISODIUM | Zydus Pharmaceuticals (USA) Inc. | 0ed73067-e2ca-4184-a93a-5a2141bb4898 | 2025-06-13 | Warnings, Adverse reactions | BALSALAZIDE DISODIUM |
| balsalazide disodium | BALSALAZIDE DISODIUM | Carnegie Pharmaceuticals, LLC | 620f86cb-b6a2-4af8-a642-925dd8a1c5fe | 2025-04-15 | Warnings, Adverse reactions | BALSALAZIDE DISODIUM |
| Balsalazide Disodium | BALSALAZIDE DISODIUM | Bryant Ranch Prepack | cd73c9f1-d83b-4206-b2c6-1bd111e11263 | 2025-04-02 | Warnings, Adverse reactions | BALSALAZIDE DISODIUM |
| Balsalazide Disodium | BALSALAZIDE DISODIUM | Golden State Medical Supply, Inc. | 029833fa-ec5c-6a39-e063-6294a90aa063 | 2025-02-18 | Warnings, Adverse reactions | BALSALAZIDE DISODIUM |
| Balsalazide Disodium | BALSALAZIDE DISODIUM | Hikma Pharmaceuticals USA Inc. | a0498308-14b2-4456-8e13-795f6fc8ea30 | 2024-02-22 | Warnings, Adverse reactions | BALSALAZIDE DISODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65649-102 | GIAZO | balsalazide disodium | Salix Pharmaceuticals, Inc | NDA | Current |
| 65649-102 | GIAZO | balsalazide disodium | Salix Pharmaceuticals, Inc | NDA | Current |
| 65649-102 | GIAZO | balsalazide disodium | Salix Pharmaceuticals, Inc | NDA | Current |