Home NDC 65649-102 GIAZO
Product NDC 65649-102
11-digit product format 656490102
Labeler code 65649
Product ID 65649-102_d1f0484a-5994-4644-a63e-da5a5a28b3c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name balsalazide disodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Salix Pharmaceuticals, Inc
Application NDA022205
Marketing category NDA
Marketing start 2012-02-03
Marketing end 2020-08-31
Substance BALSALAZIDE DISODIUM
Active strength 1 g/1
Pharmacologic classes Aminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table 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date N022205-001 GIAZO BALSALAZIDE DISODIUM 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-02-03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# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table 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.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table 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 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 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 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 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 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 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 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 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 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 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 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 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 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 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 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 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 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 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 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 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 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 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 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 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 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 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 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 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 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 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022205-001 GIAZO 1.1GM TABLET / ORAL RLD 2012-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022205-001 GIAZO 1.1GM TABLET / ORAL RLD 2012-02-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022205-001 GIAZO 1.1GM TABLET / ORAL RLD 2012-02-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 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 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022205-001 GIAZO 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 2012-02-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022205-001 GIAZO 1.1GM TABLET / ORAL RLD 2012-02-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022205-001 GIAZO 1.1GM TABLET / ORAL RLD 2012-02-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022205-001 GIAZO 1.1GM TABLET / ORAL RLD 2012-02-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022205-001 GIAZO 1.1GM TABLET / ORAL RLD 2012-02-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022205-001 GIAZO 1.1GM TABLET / ORAL RLD 2012-02-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022205-001 GIAZO 1.1GM TABLET / ORAL RLD 2012-02-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022205-001 GIAZO 1.1GM TABLET / ORAL RLD 2012-02-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 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 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 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 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 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 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 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 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 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 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 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 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 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 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 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 053a50430f4f…2023-01-26 05:58 UTC 2023-01 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 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 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 3a93d1ddd44b…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…
Observed Orange Book patent history# Patent history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022205-001 9192616 2026-08-02 U-1229 2016-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022205-001 7452872 2026-08-24 U-1229 2012-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022205-001 7625884 2026-08-24 U-1229 2012-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022205-001 8497256 2031-06-23 U-1229 2013-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022205-001 9192616 2026-08-02 U-1229 2016-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022205-001 7452872 2026-08-24 U-1229 2012-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022205-001 7625884 2026-08-24 U-1229 2012-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022205-001 8497256 2031-06-23 U-1229 2013-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022205-001 9192616 2026-08-02 U-1229 2016-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022205-001 7452872 2026-08-24 U-1229 2012-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022205-001 7625884 2026-08-24 U-1229 2012-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022205-001 8497256 2031-06-23 U-1229 2013-08-23 d06236e962d9…
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