Home Applications 021252 Application 021252
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CANASA MESALAMINE SUPPOSITORY;RECTAL 500MG No No 002 CANASA MESALAMINE SUPPOSITORY;RECTAL 1GM Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021252-001 CANASA MESALAMINE 500MG SUPPOSITORY / RECTAL 2001-01-05 N021252-002 CANASA MESALAMINE 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021252-002 AB
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021252-002 8217083 2028-06-06 Drug product 2013-05-24 N021252-002 8436051 2028-06-06 Drug product 2013-05-24
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 3 · 82 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 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 82 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 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 782e0a99824c…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021252-001 M-187 2019-09-02 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021252-001 M-187 2019-09-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021252-001 M-187 2019-09-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021252-001 M-187 2019-09-02 ea99ee380514…
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 58914-501 Canasa Mesalamine Allergan, Inc. NDA Current 58914-501 Canasa Mesalamine Allergan, Inc. NDA Current 58914-501 Canasa Mesalamine Allergan, Inc. NDA Current 58914-501 Canasa Mesalamine Allergan NDA Current 59762-0118 Mesalamine mesalamine Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-0118 Mesalamine mesalamine Greenstone LLC NDA Current 59762-0118 Mesalamine mesalamine Greenstone LLC NDA Current 59762-0118 Mesalamine mesalamine Greenstone LLC NDA Current 65084-474 Canasa Mesalamine Mckesson Rxpak Inc NDA Current