Home Applications 074461 Application 074461
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 INDAPAMIDE INDAPAMIDE TABLET;ORAL 2.5MG No Yes 002 INDAPAMIDE INDAPAMIDE TABLET;ORAL 1.25MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A074461-001 INDAPAMIDE INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 A074461-002 INDAPAMIDE INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 84 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 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL 1996-03-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL 1997-03-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL 1996-03-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL 1997-03-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL 1996-03-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL 1997-03-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB RS 1996-03-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL 1996-03-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL 1997-03-26 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 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 0378-0069 Indapamide Indapamide Mylan Pharmaceuticals Inc. ANDA Current 0378-0069 Indapamide Indapamide Mylan Pharmaceuticals Inc. ANDA Current 0378-0080 Indapamide Indapamide Mylan Pharmaceuticals Inc. ANDA Current 0378-0080 Indapamide Indapamide Mylan Pharmaceuticals Inc. ANDA Current 21695-576 Indapamide Indapamide Rebel Distributors Corp ANDA Current 50090-0510 Indapamide Indapamide A-S Medication Solutions ANDA Current 51079-868 Indapamide Indapamide Mylan Institutional Inc. ANDA Current 51079-868 Indapamide Indapamide Mylan Institutional Inc. ANDA Current 51079-868 Indapamide Indapamide Mylan Institutional Inc. ANDA Current 68151-1294 Indapamide Indapamide Carilion Materials Management ANDA Current