Home Applications 200796 Application 200796
Type NDA
Sponsor ARBOR PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EDARBI AZILSARTAN KAMEDOXOMIL TABLET;ORAL EQ 40MG MEDOXOMIL Yes No 002 EDARBI AZILSARTAN KAMEDOXOMIL TABLET;ORAL EQ 80MG MEDOXOMIL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N200796-001 EDARBI AZILSARTAN KAMEDOXOMIL EQ 40MG MEDOXOMIL TABLET / ORAL AB RLD 2011-02-25 N200796-002 EDARBI AZILSARTAN KAMEDOXOMIL EQ 80MG MEDOXOMIL TABLET / ORAL AB RLD, RS 2011-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 N200796-002 9066936 2028-03-26 Drug product 2015-07-30
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 · 88 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 2026-10-15 13:18:30 2026-09 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL AB RLD 2011-02-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL AB RLD, RS 2011-02-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL AB RLD 2011-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL AB RLD, RS 2011-02-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL AB RLD 2011-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL AB RLD, RS 2011-02-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 4b0b4de00fa7…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 2 of 7 · 244 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-002 7572920 2025-01-07 U-3 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-002 7157584 2025-05-22 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200796-001 7572920 2025-01-07 U-3 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200796-001 7157584 2025-05-22 Drug substance 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200796-002 7572920 2025-01-07 U-3 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200796-002 7157584 2025-05-22 Drug substance 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200796-001 7572920 2025-01-07 U-3 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200796-001 7157584 2025-05-22 Drug substance d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200796-002 7572920 2025-01-07 U-3 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200796-002 7157584 2025-05-22 Drug substance d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N200796-001 7572920 2025-01-07 U-3 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N200796-001 7157584 2025-05-22 Drug substance d06236e962d9…2024-10-29 15:01 UTC 2024-10 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N200796-002 7572920 2025-01-07 U-3 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N200796-002 7157584 2025-05-22 Drug substance d06236e962d9…2024-10-29 15:01 UTC 2024-10 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200796-001 7572920 2025-01-07 U-3 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200796-001 7157584 2025-05-22 Drug substance 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200796-002 7572920 2025-01-07 U-3 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200796-002 7157584 2025-05-22 Drug substance 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200796-001 7572920 2025-01-07 U-3 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200796-001 7157584 2025-05-22 Drug substance 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200796-002 7572920 2025-01-07 U-3 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200796-002 7157584 2025-05-22 Drug substance 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200796-001 7572920 2025-01-07 U-3 Drug product 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200796-001 7157584 2025-05-22 Drug substance 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200796-002 7572920 2025-01-07 U-3 Drug product 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200796-002 7157584 2025-05-22 Drug substance 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 1e350fbaab3a…
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 · 2 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 60631-040 Edarbi Azilsartan kamedoxomil Arbor Pharmaceuticals NDA Current 60631-040 Edarbi Azilsartan kamedoxomil Arbor Pharmaceuticals NDA Current 60631-040 Edarbi Azilsartan kamedoxomil Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) NDA Current 60631-040 Edarbi Azilsartan kamedoxomil Arbor Pharmaceuticals NDA Current 60631-080 Edarbi Azilsartan kamedoxomil Arbor Pharmaceuticals NDA Current 60631-080 Edarbi Azilsartan kamedoxomil Arbor Pharmaceuticals NDA Current 60631-080 Edarbi Azilsartan kamedoxomil Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) NDA Current 60631-080 Edarbi Azilsartan kamedoxomil Arbor Pharmaceuticals NDA Current