Home Applications 202331 Application 202331
Type NDA
Sponsor ARBOR PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EDARBYCLOR AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE TABLET;ORAL EQ 40MG MEDOXOMIL;12.5MG Yes No 002 EDARBYCLOR AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE TABLET;ORAL EQ 40MG MEDOXOMIL;25MG 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 N202331-001 EDARBYCLOR AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB RLD 2011-12-20 N202331-002 EDARBYCLOR AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB RLD, RS 2011-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202331-001 9066936 2028-03-26 Drug product 2015-07-30 N202331-001 9169238 2030-02-04 Drug product 2015-11-19 N202331-001 9387249 2031-07-01 U-3 2019-08-15 N202331-002 9066936 2028-03-26 Drug product 2015-07-30 N202331-002 9169238 2030-02-04 Drug product 2015-11-19 N202331-002 9387249 2031-07-01 U-3 2019-08-15
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 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB RLD 2011-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB RLD, RS 2011-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB RLD 2011-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB RLD, RS 2011-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB RLD 2011-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB RLD, RS 2011-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB RLD 2011-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB RLD, RS 2011-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB RLD 2011-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB RLD, RS 2011-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 10 · 400 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 N202331-001 9066936 2028-03-26 Drug product 2015-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202331-001 9169238 2030-02-04 Drug product 2015-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202331-001 9387249 2031-07-01 U-3 2019-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202331-002 9066936 2028-03-26 Drug product 2015-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202331-002 9169238 2030-02-04 Drug product 2015-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202331-002 9387249 2031-07-01 U-3 2019-08-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-001 7572920 2025-01-07 U-3 Drug product 2012-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-001 7157584 2025-05-22 Drug substance 2012-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-001 9066936 2028-03-26 Drug product 2015-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-001 9169238 2030-02-04 Drug product 2015-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-001 9387249 2031-07-01 U-3 2019-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-002 7572920 2025-01-07 U-3 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-002 7157584 2025-05-22 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-002 9066936 2028-03-26 Drug product 2015-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-002 9169238 2030-02-04 Drug product 2015-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-002 9387249 2031-07-01 U-3 2019-08-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202331-001 7572920 2025-01-07 U-3 Drug product 2012-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-001 7157584 2025-05-22 Drug substance 2012-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-001 9066936 2028-03-26 Drug product 2015-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-001 9169238 2030-02-04 Drug product 2015-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-001 9387249 2031-07-01 U-3 2019-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-002 7572920 2025-01-07 U-3 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-002 7157584 2025-05-22 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-002 9066936 2028-03-26 Drug product 2015-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-002 9169238 2030-02-04 Drug product 2015-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-002 9387249 2031-07-01 U-3 2019-08-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-001 7572920 2025-01-07 U-3 Drug product 2012-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-001 7157584 2025-05-22 Drug substance 2012-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-001 9066936 2028-03-26 Drug product 2015-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-001 9169238 2030-02-04 Drug product 2015-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-001 9387249 2031-07-01 U-3 2019-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-002 7572920 2025-01-07 U-3 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-002 7157584 2025-05-22 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-002 9066936 2028-03-26 Drug product 2015-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-002 9169238 2030-02-04 Drug product 2015-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-002 9387249 2031-07-01 U-3 2019-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202331-001 7572920 2025-01-07 U-3 Drug product 2012-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202331-001 7157584 2025-05-22 Drug substance 2012-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202331-001 9066936 2028-03-26 Drug product 2015-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202331-001 9169238 2030-02-04 Drug product 2015-11-19 b8a1b40f171c…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Edarbyclor AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) e60f795b-fce3-4361-aa03-f143451689d1 2022-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202331 application number: NDA202331 ndc (product): 60631-425 ndc (product): 60631-412
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 60631-412 Edarbyclor Azilsartan kamedoxomil and chlorthalidone Arbor Pharmaceuticals NDA Current 60631-412 Edarbyclor Azilsartan kamedoxomil and chlorthalidone Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) NDA Current 60631-412 Edarbyclor Azilsartan kamedoxomil and chlorthalidone Arbor Pharmaceuticals NDA Current 60631-412 Edarbyclor Azilsartan kamedoxomil and chlorthalidone Arbor Pharmaceuticals NDA Current 60631-425 Edarbyclor Azilsartan kamedoxomil and chlorthalidone Arbor Pharmaceuticals NDA Current 60631-425 Edarbyclor Azilsartan kamedoxomil and chlorthalidone Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) NDA Current 60631-425 Edarbyclor Azilsartan kamedoxomil and chlorthalidone Arbor Pharmaceuticals NDA Current 60631-425 Edarbyclor Azilsartan kamedoxomil and chlorthalidone Arbor Pharmaceuticals NDA Current