Home Applications 020386 Application 020386
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COZAAR LOSARTAN POTASSIUM TABLET;ORAL 25MG Yes No 002 COZAAR LOSARTAN POTASSIUM TABLET;ORAL 50MG Yes No 003 COZAAR LOSARTAN POTASSIUM TABLET;ORAL 100MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020386-001 COZAAR LOSARTAN POTASSIUM 25MG TABLET / ORAL AB RLD 1995-04-14 N020386-002 COZAAR LOSARTAN POTASSIUM 50MG TABLET / ORAL AB RLD 1995-04-14 N020386-003 COZAAR LOSARTAN POTASSIUM 100MG TABLET / ORAL AB RLD, RS 1998-10-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 126 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 2026-08-18 06:07:40 2026-07 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 110 observed states.
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 · 30 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-0951 COZAAR losartan potassium Merck Sharp & Dohme Corp. NDA Current 0006-0951 COZAAR losartan potassium Merck Sharp & Dohme Corp. NDA Current 0006-0951 COZAAR losartan potassium Merck Sharp & Dohme Corp. NDA Current 0006-0951 COZAAR losartan potassium Merck Sharp & Dohme Corp. NDA Current 0006-0952 COZAAR losartan potassium Merck Sharp & Dohme Corp. NDA Current 0006-0952 COZAAR losartan potassium Merck Sharp & Dohme Corp. NDA Current 0006-0952 COZAAR losartan potassium Merck Sharp & Dohme Corp. NDA Current 0006-0952 COZAAR losartan potassium Merck Sharp & Dohme Corp. NDA Current 0006-0960 COZAAR losartan potassium Merck Sharp & Dohme Corp. NDA Current 0006-0960 COZAAR losartan potassium Merck Sharp & Dohme Corp. NDA Current 0006-0960 COZAAR losartan potassium Merck Sharp & Dohme Corp. NDA Current 0006-0960 COZAAR losartan potassium Merck Sharp & Dohme Corp. NDA Current 0781-5805 Losartan Potassium losartan potassium Sandoz Inc. NDA Current 0781-5806 Losartan Potassium losartan potassium Sandoz Inc. NDA Current 0781-5807 Losartan Potassium losartan potassium Sandoz Inc. NDA Current 55289-238 COZAAR losartan potassium PD-Rx Pharmaceuticals, In NDA Current 55289-238 COZAAR losartan potassium PD-Rx Pharmaceuticals, Inc. NDA Current 55289-238 COZAAR losartan potassium PD-Rx Pharmaceuticals, Inc. NDA Current 55289-238 COZAAR losartan potassium PD-Rx Pharmaceuticals, Inc. NDA Current 55289-238 COZAAR losartan potassium PD-Rx Pharmaceuticals, Inc. NDA Current 63629-2912 COZAAR losartan potassium Bryant Ranch Prepack NDA Current 78206-121 COZAAR losartan potassium Organon LLC NDA Current 78206-121 COZAAR losartan potassium Organon LLC NDA Current 78206-121 COZAAR losartan potassium Organon LLC NDA Current 78206-122 COZAAR losartan potassium Organon LLC NDA Current 78206-122 COZAAR losartan potassium Organon LLC NDA Current 78206-122 COZAAR losartan potassium Organon LLC NDA Current 78206-123 COZAAR losartan potassium Organon LLC NDA Current 78206-123 COZAAR losartan potassium Organon LLC NDA Current 78206-123 COZAAR losartan potassium Organon LLC NDA Current