Home Applications 091541 Application 091541
Type ANDA
Sponsor MICRO LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG No No 002 LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG No No 003 LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG No No
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 A091541-001 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 A091541-002 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 A091541-003 LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24
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 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091541-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091541-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091541-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091541-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091541-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091541-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091541-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091541-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091541-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091541-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091541-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091541-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091541-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091541-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091541-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091541-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091541-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091541-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091541-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091541-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091541-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091541-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091541-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091541-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091541-002 LOSARTAN POTASSIUM 50MG TABLET / ORAL AB 2012-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091541-003 LOSARTAN POTASSIUM 100MG TABLET / ORAL AB 2012-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091541-001 LOSARTAN POTASSIUM 25MG TABLET / ORAL AB 2012-09-24 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42571-110 LOSARTAN POTASSIUM losartan potassium Micro Labs Limited ANDA Current 42571-110 LOSARTAN POTASSIUM losartan potassium Micro Labs Limited ANDA Current 42571-111 LOSARTAN POTASSIUM losartan potassium Micro Labs Limited ANDA Current 42571-111 LOSARTAN POTASSIUM losartan potassium Micro Labs Limited ANDA Current 42571-112 LOSARTAN POTASSIUM losartan potassium Micro Labs Limited ANDA Current 42571-112 LOSARTAN POTASSIUM losartan potassium Micro Labs Limited ANDA Current 50090-4252 LOSARTAN POTASSIUM losartan potassium A-S Medication Solutions ANDA Current 50090-4252 LOSARTAN POTASSIUM losartan potassium A-S Medication Solutions ANDA Current 71335-1136 LOSARTAN POTASSIUM losartan potassium Bryant Ranch Prepack ANDA Current 71335-1136 LOSARTAN POTASSIUM losartan potassium Bryant Ranch Prepack ANDA Current