Home Applications 203020 Application 203020
Type ANDA
Sponsor UNICHEM LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IRBESARTAN IRBESARTAN TABLET;ORAL 75MG No No 002 IRBESARTAN IRBESARTAN TABLET;ORAL 150MG No No 003 IRBESARTAN IRBESARTAN TABLET;ORAL 300MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A203020-001 IRBESARTAN IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 A203020-002 IRBESARTAN IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 A203020-003 IRBESARTAN IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07
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 · 123 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 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 105 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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 29300-212 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-212 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-212 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-212 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-212 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-212 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-213 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-213 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-213 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-213 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-213 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-213 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-214 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-214 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-214 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-214 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-214 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-214 Irbesartan Irbesartan Unichem Pharmaceuticals (USA), Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 10146 ORIG 2015-12-09